Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling LaserEdge ophthalmic knives because of 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 taken due to quality control issues (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, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A. The recall involves 1,236,749 knives that were distributed nationwide in the United States. These sterile, prescription-only instruments are intended for use in ophthalmic surgery.
The recall was initiated after the company's complaints database was reviewed, revealing 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.
Healthcare providers and facilities that have received these products should stop using them and contact the manufacturer for further instructions. The source text does not report any specific illnesses or injuries associated with the recalled knives.
The recalled product
- Product
- LASEREDGE Knives, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A, 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
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