MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled
FDA device recall Z-2441-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- Alcon Laboratories, Inc
- Reason for recall
- Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.
- Action taken
- The recalling firm notified healthcare professional consignees and affiliated foreign distributors by letter on 07/07/08 and advised of the mislabeled device and potential hazard associated with delivery of the IOL. Consignees were instructed to return identified lots in their inventory and to return the enclosed business reply card for product replacement. Contact Stericycle Inc at 1-800-668-4391 for assistance with returning the recalled product. Contact Alcon Customer Service at 1-800-862-5266 for questions about the recall.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- KYB
- Quantity affected
- 7962 units
- Distribution
- Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
- Date initiated
- 2008-07-07
- Date posted
- 2008-09-23
- Date terminated
- 2009-08-26
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONARCH II IOL DELIVERY SYSTEM (K001157) | Alcon Research, Ltd. | 2000-06-27 |