FDA recall Z-0875-2018

Bausch & Lomb Inc Irb · Class II · device

Product

LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG, 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.

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.

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2017-03-03
Report date
2018-03-14
Termination date
2018-06-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0875-2018