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 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 Inc Irb is voluntarily recalling LASEREDGE Knives, 1.6MM X 1.8MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7600. These sterile, prescription-only medical devices are intended for use in ophthalmic surgery procedures. The recall covers 1,236,749 knives in total that were distributed nationwide in the United States.
The recall was initiated after the company's complaints database was reviewed, revealing an atypical volume of complaints regarding dull blades for various lots. As a precautionary measure, Bausch & Lomb is recalling all product codes manufactured without electro-polish control and penetration force testing.
These products are intended for use by surgeons in ophthalmic surgery. There is no therapeutic use for these devices outside of surgical procedures. Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- LASEREDGE Knives, 1.6MM X 1.8MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7600, 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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