Recall Z-0167-2012 ยท HNO Keratome, Ac-Powered
AMO Manufacturing USA, LLC
Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoi
| Date | Nov 4, 2011 (initiated Oct 12, 2011) |
| Status | Terminated |
| Reason | The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System. |
| Root cause | Process design |
| Action | Abbott Medical Optics Inc. (AMO) issued an "ADVISORY NOTICE" letter dated October 12, 2011 to all affected customers. The letter identifies the affected products, the problem, and the actions needed to be taken. Customers were instructed to exercise caution when making cuts that approach the corneal endothelium. The letter includes a 1-page Operator's Manual addendum that clarifies the recommendations. The letter states that AMO will conduct a field correction to adjust the EOF on the affected FS Laser Systems. The letter includes a response form to be completed and returned as per the inst |
| Quantity | 1226 total laser systems |
| Distribution | Worldwide Distribution - USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031960 | INTRALASE FS LASER Intra Lase Corp., Sep 29, 2003 |