Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives nationwide due to an atypical volume of complaints regarding dull blades.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (dull surgical blades) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Bausch & Lomb Inc Irb is voluntarily recalling 1,236,749 units of LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519. These sterile, prescription-only surgical instruments are intended for ophthalmic surgery and 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. The recall covers all product codes manufactured without electro-polish control and penetration force testing.
This is a Class II recall, indicating a situation that could temporarily cause serious adverse health consequences or where the probability of serious adverse health consequences is remote. No specific illnesses or injuries are reported in the source text. Healthcare providers should stop using the affected product codes and contact the manufacturer for further instructions.
The recalled product
- Product
- LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, 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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