Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blade Complaints
Bausch & Lomb Inc Irb is voluntarily recalling LASEREDGE Knives intended for ophthalmic surgery because of an atypical volume of complaints regarding dull blades.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is FDA Class II due to a risk of harm (dull blades) where injury has not yet been reported, which aligns with the High severity criteria. It does not meet the threshold for Severe or Critical as there are no reports of hospitalization, death, or serious injury.
Plain-English summary
Bausch & Lomb Inc Irb is voluntarily recalling LASEREDGE Knives, specifically the 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED product (REF/PRODUCT CODE E7601G), which are sterile and intended for use in ophthalmic surgery procedures. The recall affects a total of 1,236,749 knives distributed nationwide across the United States.
The decision to recall was made after reviewing the complaints database, which revealed an atypical volume of reports concerning dull blades for various lots. Consequently, the firm is recalling all product codes and SKUs that were manufactured without electro-polish control and penetration force testing.
No specific lot numbers, dates, or reported injuries are listed in the provided source text. Consumers who possess these knives should refer to the official recall notice for further instructions.
The recalled product
- Product
- LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7601G, 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
- 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.
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