Bausch & Lomb Inc Irb: Medical Device Recall in 2018 - (Recall #: Z-0870-2018)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2018.
Data Source: FDA.
Product Description:
LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7550ADB, 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.
Product Classification:
Class II
Date Initiated: March 3, 2017
Date Posted: March 14, 2018
Recall Number: Z-0870-2018
Event ID: 76874
Reason for Recall:
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.
Status: Terminated
Product Quantity: 1,236,749 knives in total
Code Information:
none
Distribution Pattern:
US Nationwide Distribution
Voluntary or Mandated:
Voluntary: Firm initiated