Device product
LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, 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.
Z-0891-2018
Product summary
- Event
- Event 76874
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,236,749 knives in total
- Official record key
device-enforcement:Z-0891-2018
Official wording
Reason: 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.
Code information: none
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.