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Terminated

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

FDA Recall Z-2366-2019 · Posted None

Recalling FirmBausch & Lomb Inc Irb
Recall StatusTerminated
Product CodeHNN
Date Initiated2016-07-11
Date Terminated2019-08-30
Product Quantity165 packs/6 blades (990 individiual blades)

Reason for Recall

Possible dull knife edge

Firm Action

On July 14, 2016, Baush + Lomb issued Medical Device Voluntary Product Recall notices to customers. Customers were instructed to take the following actions: 1. Please review your inventory and hold all unused boxes 2. Quarantine any unused boxes (full and partial) and take the following steps to return the product to Bausch + Lomb at the recalling firm's expense. 3. Please complete the Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2).

Root Cause

Vendor change control

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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