Recall Z-2365-2019 ยท HNN Knife, Ophthalmic
Bausch & Lomb Inc Irb
Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
| Date | Jul 11, 2016 |
| Status | Terminated |
| Reason | Possible dull knife edge |
| Root cause | Vendor change control |
| 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 |
| Quantity | 384 packs/6 blades (2,304 individual blades) |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.