Recall Z-1575-05 ยท LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Alcon Research, Ltd
Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the descri
| Date | Sep 21, 2005 (initiated Sep 2, 2005) |
| Status | Terminated |
| Reason | Unknown residue noted on suface of flap irrigators incorporated into cusom paks. |
| Root cause | Other |
| Action | Firm notified consignee by letter on 9/2/2005. |
| Quantity | 75 units |
| Distribution | Lake Charles, LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.