Fort Worth, TX, United States
Alcon Research LLC recalls
28 recalls recorded since 2018, most recently on 21 April 2026. 22 are listed as ongoing. Status and classification are as published by the FDA.
Recalls28
Ongoing (FDA)22
Terminated or completed6
Class I (FDA)3
Ongoing Class II Drugs
- Recall started
- 21 April 2026
- Reason
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0492-2026, D-0491-2026
- GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.
- Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
Ongoing Class I Medical devices
- Recall started
- 24 November 2025
- Reason
- Ophthalmic procedure packs may have incomplete seals affecting sterility.
- Distribution
- US Nationwide distribution in the states of CA, ND, UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0939-2026
- Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are custom
Ongoing Class II Medical devices
- Recall started
- 30 September 2025
- Reason
- Potential for a weak seal in some units resulting in compromise in sterility.
- Distribution
- Worldwide - US distribution in the states of Alabama, Arizona, Arkansas, Connecticut, Florida, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oklahoma, Oregon, Tennessee, Texas, Washington and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0326-2026
- Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Ongoing Class II Medical devices
- Recall started
- 15 September 2025
- Reason
- XXX
- Distribution
- Worldwide - US Nationwide distribution including in the states of PA, MN, CA, FL, LA, CO, KS, IL, AK, OH, NY, NM, DE, TX, GA, NJ, MI, SC, AR, IN, OR, VA, WI, AZ, TN, KY, AL, MA, WA, NE, MT, SD, CT, NC, MO, UT, WY, DC, NH, MD, ID, RI, ND, HI, ME, IA, MS, NV, OK, WV, VT and the countries of GB, CA, IE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0581-2026
- CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8
Ongoing Class II Medical devices
- Recall started
- 5 August 2025
- Reason
- Due to incomplete seals in the pouch which provide the sterile barrier.
- Distribution
- Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerba
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0305-2026, Z-0307-2026, Z-0306-2026, Z-0304-2026, Z-0308-2026
- Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS
- Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDEL
- Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FL
- Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVI
- Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTE
Ongoing Class II Medical devices
- Recall started
- 28 April 2025
- Reason
- Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Albania, Ar
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2108-2025, Z-2109-2025, Z-2110-2025
- Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Descriptio
- Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description:
- Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed
Ongoing Class II Medical devices
- Recall started
- 10 February 2025
- Reason
- Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.
- Distribution
- US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1293-2025
- Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-1
Ongoing Class I Drugs
- Recall started
- 18 December 2024
- Reason
- Non-Sterility
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0200-2025
- Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Ongoing Class II Medical devices
- Recall started
- 13 November 2024
- Reason
- Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.
- Distribution
- US: AK AL AR AZ CA CO CT DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY OUS: Russia, Egypt
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0835-2025
- Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A
Ongoing Class III Medical devices
- Recall started
- 15 October 2024
- Reason
- Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
- Distribution
- US distribution to states of: Delaware, Illinois, and Oklahoma
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0490-2025
- a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing
Ongoing Class II Medical devices
- Recall started
- 8 August 2024
- Reason
- Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision.
- Distribution
- US: UT, TX, NC, MT, AL, WA, MS, PA, LA, MI, GA, FL, KY, OH, AZ, IL, CA, NJ, TN, NY, AR, MN, WI, MD, OK, SC, OR, MA, CO, VA, CT, IA, DE, WV, MO, ID, SD, NE, NV, IN, ME, VT, NM, NH, AK, HI, KS, RI, WY, PR, DC. OUS: GB, NL, HK, ES, PL, IT, FR, CA, CH, PT, AT, DE, NO, GG, LU, CZ, SK, DK, FI, SE, IN, OM
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3313-2024
- DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Ongoing Class II Medical devices
- Recall started
- 15 July 2024
- Reason
- Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- Distribution
- Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Ma
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2664-2024, Z-2673-2024, Z-2665-2024, Z-2667-2024, Z-2655-2024, Z-2659-2024, Z-2658-2024, Z-2662-2024, Z-2661-2024, Z-2654-2024, Z-2649-2024, Z-2656-2024 and 24 more
- Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A
- Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- and 28 more product lines
Ongoing Class II Medical devices
- Recall started
- 23 May 2024
- Reason
- After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI, PR and the countries of Canada, Japan, France.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2412-2024
- Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Ongoing Class II Medical devices
- Recall started
- 22 April 2024
- Reason
- Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Netherlands, New Zealand,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1925-2024, Z-1922-2024, Z-1924-2024, Z-1923-2024
- ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
- 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
- ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Ongoing Class II Medical devices
- Recall started
- 15 March 2024
- Reason
- Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
- Distribution
- Worldwide distribution - U.S. Nationwide including in the states of AK, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Australia, Canada, and New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1606-2024
- Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. T
Ongoing Class II Medical devices
- Recall started
- 21 February 2024
- Reason
- Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.
- Distribution
- US Nationwide distribution in the states of OH, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1370-2024
- SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554
Ongoing Class II Medical devices
- Recall started
- 7 September 2023
- Reason
- Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
- Distribution
- US: VA OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0260-2024
- Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Ongoing Class II Medical devices
- Recall started
- 18 August 2023
- Reason
- Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.
- Distribution
- US: GA, IL, PR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0099-2024
- Constellation Vision System, REF: 8065751150
Ongoing Class II Medical devices
- Recall started
- 28 June 2023
- Reason
- Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Aland Islands, Albania, Algeria, Andorran, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bermuda, Botswana, Brazil, Brunei Daruss., Bulgaria, Burma, Cambodia, Canada, Ca
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2407-2023, Z-2409-2023, Z-2406-2023, Z-2408-2023, Z-2411-2023, Z-2410-2023
- Centurion FMS Pak
- Legion FMS Pak
- Constellation Procedure Pak
- Infinity FMS Pak
- Alcon Custom Pak
- Phaco Standalone Tips
Ongoing Class II Medical devices
- Recall started
- 10 March 2023
- Reason
- Sterility; Steril surgical procedure packs contain incomplete seals.
- Distribution
- US: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1291-2023
- Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF
Ongoing Class II Medical devices
- Recall started
- 31 October 2022
- Reason
- Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.
- Distribution
- Worldwide Distribution: U.S.(nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and O.U.S. (foreign) to countries of: Austral
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0354-2023
- Alcon Custom Pak Surgical Procedure Pack
Ongoing Class II Medical devices
- Recall started
- 9 June 2022
- Reason
- Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
- Distribution
- U.S.: AZ, CA, MO, and NY O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1373-2022
- Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS
Terminated Class II Medical devices
- Recall started
- 2 February 2021
- Terminated
- 30 June 2023
- Reason
- Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
- Distribution
- Distribution US nationwide, including Puerto Rico; Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1328-2021
- Alcon Custom Ophthalmic Surgical Procedure Packs
Terminated Class II Medical devices
- Recall started
- 24 August 2020
- Terminated
- 17 November 2021
- Reason
- The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.
- Distribution
- U.S. Nationwide distribution including in the states of AK, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MN, MO, NE, NJ, NV, NY, OK, PA, TN, TX, UT, WA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0095-2021
- Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
Terminated Class II Medical devices
- Recall started
- 17 April 2020
- Terminated
- 5 February 2021
- Reason
- Incorrect IOL diopter
- Distribution
- US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2287-2020
- Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS
Terminated Class I Medical devices
- Recall started
- 28 August 2018
- Terminated
- 18 December 2020
- Reason
- Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Finland, Germany, Hong Kong, Iceland, Italy, Mexico, Peru, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Urugua
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0185-2019, Z-0186-2019, Z-0187-2019, Z-0188-2019
- CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
- CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
- CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
- CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
Terminated Class II Medical devices
- Recall started
- 25 July 2018
- Terminated
- 24 April 2020
- Reason
- There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.
- Distribution
- There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1794-2020
- Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
Terminated Class II Medical devices
- Recall started
- 12 January 2018
- Terminated
- 4 February 2022
- Reason
- Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.
- Distribution
- Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0778-2018, Z-0779-2018
- Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
- Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.