Device product

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

Z-2365-2019

July 11, 2016

Class II

Product summary

Firm: Bausch & Lomb Inc Irb
Event: Event 74671
Status: Terminated
Classification: Class II
Quantity: 384 packs/6 blades (2,304 individual blades)
Official record key: device-enforcement:Z-2365-2019

Official wording

Reason: Possible dull knife edge

Code information: Lot Numbers: MAWS530 MAXA950 Expiry Dates: 01-2021

Distribution pattern: US Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Possible dull knife edge