Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb Inc is voluntarily recalling LASEREDGE Knives for ophthalmic surgery 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 involving a medical device with a defect (dull blades) that poses a risk of harm during surgery. Although no illnesses or injuries are reported, the potential for injury in a surgical context warrants a High severity rating.
Plain-English summary
Bausch & Lomb Inc Irb is voluntarily recalling LASEREDGE Knives, specifically the CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX) with REF/PRODUCT CODE E7528G. These sterile, Rx-only knives are intended for use by surgeons in ophthalmic procedures.
The recall was initiated after a review of the complaints database revealed an atypical volume of reports regarding dull blades for various lots. To mitigate this risk, Bausch & Lomb is recalling all product codes manufactured without electro-polish control and penetration force testing.
Approximately 1,236,749 knives are affected by this recall. The products were distributed nationwide across the United States. No specific lot numbers or dates of distribution are provided in the source text.
The recalled product
- Product
- LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, 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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