FDA recall Z-2365-2019

Bausch & Lomb Inc Irb · Class II · device

Product

Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.

Reason for recall

Possible dull knife edge

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2016-07-11
Report date
2019-09-04
Termination date
2019-08-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2365-2019