Product Wiki · Recalls · U.S. FDA — Device Enforcement

LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX)… — recall Z-0863-2018

U.S. FDA — Device Enforcement · United States · 2017-03-03 · Class II

As described by U.S. FDA — Device Enforcement: LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0863-2018
Date of alert
2017-03-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bausch & Lomb Inc Irb
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide Distribution
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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