Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch + Lomb is voluntarily recalling 1,236,749 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 a voluntary precautionary action 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 1,236,749 units of LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG. These sterile, prescription-only devices are intended for use in ophthalmic surgery procedures. The recall covers 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 is recalling the affected products out of an abundance of precaution.
The affected knives were distributed nationwide in the United States. Healthcare providers and patients should stop using the recalled devices and contact Bausch + Lomb for further instructions.
The recalled product
- Product
- LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG, 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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