Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb Inc is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because an atypical volume of complaints indicates dull blades. The recall affects products lacking specific electro-polish and penetration force testing.
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, which typically corresponds to a High severity score (3) under the rubric. The hazard involves defective medical devices (dull blades) that pose a risk of harm during surgery, but no illnesses or injuries have been reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has announced that Bausch & Lomb Inc is voluntarily recalling LASEREDGE Knives, specifically the CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX) with REF/PRODUCT CODE E7500. The total quantity affected is 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 reports regarding dull blades for various lots. Bausch & Lomb is taking this precautionary measure for all product codes manufactured without electro-polish control and penetration force testing.
These sterile, Rx-only knives are intended for use by surgeons in ophthalmic surgery procedures and have no therapeutic use. Consumers or medical professionals with these specific knives should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, 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.
See all 44 products in this recall →Related recalls
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