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Recall Observatory FDA recall evidence

Device product

Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.

Z-2366-2019

July 11, 2016

Class II

Product summary

Firm
Bausch & Lomb Inc Irb
Event
Event 74671
Status
Terminated
Classification
Class II
Quantity
165 packs/6 blades (990 individiual blades)
Official record key
device-enforcement:Z-2366-2019

Official wording

Reason: Possible dull knife edge

Code information: Lot Number: MAXZ170 Expiry Date: 01/28/2021

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possible dull knife edge