Lancaster, NY, United States
Alden Optical recalls
2 recalls recorded since 2018, most recently on 3 July 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 3 July 2018
- Terminated
- 28 February 2020
- Reason
- Vials labeled for the prescriptions contained incorrect lenses
- Distribution
- US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2981-2018, Z-2982-2018
- Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral C
- Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenl
Terminated Class II Medical devices
- Recall started
- 3 November 2017
- Terminated
- 19 June 2018
- Reason
- Contact lenses lack sterility assurance.
- Distribution
- Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0982-2018, Z-0983-2018, Z-0981-2018, Z-0990-2018, Z-0987-2018, Z-0984-2018, Z-0989-2018, Z-0988-2018, Z-0985-2018, Z-0986-2018, Z-0991-2018
- NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametrop
- Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with no
- NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia
- Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseas
- Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseas
- Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-
- Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-
- Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseas
- and 3 more product lines
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.