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Bausch & Lomb Inc Irb recalls LASEREDGE Knives, 1.6MM X 1.8MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7600, STERILE, Rx Only Product Usage: T
Recalled March 14, 2018 · FDA recall Z-0890-2018 · Bausch & Lomb Inc Irb
Hazard
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing. · FDA Class II
Units
1,236,749 knives in total
Sold at
US Nationwide Distribution
Description
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
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(s)
Bausch & Lomb Inc Irb
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →