Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling specific LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary measure based on quality complaints (dull blades) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Bausch & Lomb Inc Irb is voluntarily recalling LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527. The recalled products are sterile, prescription-only surgical instruments intended for ophthalmic surgery. The recall covers 1,236,749 knives distributed nationwide in the United States.
The recall was initiated after a review of the complaints database revealed an atypical volume of complaints regarding dull blades for various lots. As a precautionary measure, Bausch & Lomb is recalling all product codes manufactured without electro-polish control and penetration force testing.
These products are intended for use by surgeons in ophthalmic procedures. There is no therapeutic use for the general public. Healthcare facilities and surgeons should stop using the affected product codes and contact the manufacturer for further instructions.
The recalled product
- Product
- LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
- Manufacturer
- Bausch & Lomb Inc Irb
- Hazard
- Affected units
- 1,236,749
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- none
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 44 recalled by Bausch & Lomb Inc Irb under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 44 products in this recall →Related recalls
Same manufacturer · Bausch & Lomb Inc Irb
See all →- ModerateBausch & Lomb Recalls Laseredge Knives Due to Possible Dull Edge
FDA (Devices) · 2019-09-04
- ModerateBausch & Lomb Recalls Laseredge 1.1mm Arrow Knife Due to Dull Edge
FDA (Devices) · 2019-09-04
- ModerateBausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
FDA (Devices) · 2018-03-14
- ModerateBausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
FDA (Devices) · 2018-03-14
- ModerateBausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
FDA (Devices) · 2018-03-14
Same hazard · dull blade
See all →- HighAlcon ophthalmic surgical knives recalled for sharpness defects
FDA (Devices) · 2024-08-28
- HighSX-One MicroKnife Recalled for Potential Dull Blade Defect
FDA (Devices) · 2022-07-27
- ModerateBausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
FDA (Devices) · 2018-03-14
- ModerateBausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
FDA (Devices) · 2018-03-14
- ModerateBausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
FDA (Devices) · 2018-03-14