Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product
FDA device recall Z-0165-2012 · posted 2011-11-04 · Terminated
Recall details
- Recalling firm
- AMO Manufacturing USA, LLC
- Reason for recall
- 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.
- Action taken
- 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 instructions. Customers were instructed to notify all appropriate staff/personnel of the Advisory Notice. For any further questions regarding the information or recommendations, contact an AMO representative at 1-800-266-3375
- Root cause
- Process design
- Status
- Terminated
- Product code
- HNO
- Quantity affected
- 1226 total laser systems
- Distribution
- Worldwide Distribution - USA (nationwide)
- Date initiated
- 2011-10-12
- Date posted
- 2011-11-04
- Date terminated
- 2013-05-01
- Location
- Milpitas, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRALASE FS LASER (K031960) | Intra Lase Corp. | 2003-09-29 |