Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives used in 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 classified as FDA Class II, but the source text describes it as a voluntary precautionary measure due to quality complaints (dull blades) without any reported injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Bausch + Lomb Inc Irb is voluntarily recalling 1,236,749 units of LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528. These sterile, prescription-only surgical instruments are intended for use in ophthalmic surgery. The recall covers all product codes manufactured without electro-polish control and penetration force testing.
The recall was initiated after the company's complaints database was reviewed, revealing an atypical volume of complaints regarding dull blades for various lots. Bausch + Lomb stated that the recall is being conducted out of an abundance of precaution.
The affected products were distributed nationwide in the United States. The source text does not specify specific lot numbers or dates of manufacture. Healthcare providers and patients should contact Bausch + Lomb for further instructions on how to return or replace the affected devices.
The recalled product
- Product
- LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, 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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