Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives 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 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 is voluntarily recalling 1,236,749 units of LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510G, STERILE, Rx Only. The product is intended for ophthalmic surgery and is available to surgeons for use in procedures.
The recall was initiated after the company's complaints database was reviewed and an atypical volume of complaints regarding dull blades was identified for various lots. Out of an abundance of precaution, Bausch + Lomb is recalling all product codes manufactured without the electro-polish control and penetration force testing.
The affected products were distributed nationwide in the United States. The source text does not specify instructions for consumers or healthcare providers regarding the return or disposal of the recalled items.
The recalled product
- Product
- LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510G, 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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