Bausch & Lomb Recalls LaserEdge Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling LaserEdge Knives intended for ophthalmic surgery 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 voluntary and precautionary, initiated due to an atypical volume of complaints about dull blades, with no reported injuries or illnesses.
Plain-English summary
Bausch & Lomb Inc Irb is voluntarily recalling LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, STERILE, Rx Only. The product is intended for ophthalmic surgery and is available to surgeons for use in procedures. The recall covers 1,236,749 knives in total, which were distributed nationwide in the US.
The recall was initiated after the company's complaints database was reviewed, revealing an atypical volume of complaints regarding dull blades for various lots. Out of an abundance of precaution, Bausch & Lomb is recalling all product codes manufactured without electro-polish control and penetration force testing.
No specific lot numbers or dates are provided in the source text. The recall is voluntary and precautionary.
The recalled product
- Product
- LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, 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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