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

LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, 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. — recall Z-0869-2018

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

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0869-2018
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
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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.