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 action taken due to quality complaints (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, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7552ADB. The sterile, prescription-only devices are intended for use in ophthalmic surgery. The recall covers products manufactured without electro-polish control and penetration force testing.
The recall was initiated after a review of the complaints database revealed 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. No specific lot numbers or dates of manufacture are provided in the source text. Healthcare providers and patients should stop using the affected knives and contact Bausch & Lomb for further instructions.
The recalled product
- Product
- LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7552ADB, 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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