Rochester, NY, United States
Bausch & Lomb Inc Irb recalls
2 recalls recorded since 2018, most recently on 3 March 2017. 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 II Medical devices
- Recall started
- 3 March 2017
- Terminated
- 25 June 2018
- Reason
- The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0888-2018, Z-0882-2018, Z-0864-2018, Z-0868-2018, Z-0873-2018, Z-0852-2018, Z-0866-2018, Z-0874-2018, Z-0859-2018, Z-0853-2018, Z-0876-2018, Z-0856-2018 and 32 more
- LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are availabl
- LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are availabl
- LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7529, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and th
- LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are a
- LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7551ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and t
- LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are
- LASEREDGE Knives, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are availab
- LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/PRODUCT CODE E7551ADBG, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic
- and 36 more product lines
Terminated Class II Medical devices
- Recall started
- 11 July 2016
- Terminated
- 30 August 2019
- Reason
- Possible dull knife edge
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2365-2019, Z-2366-2019
- Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
- Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
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.