Recall Z-2441-2008 ยท KYB Lens, Guide, Intraocular
Alcon Laboratories, Inc
MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract removal. Each cartridge is imprinted with the model type on the wing of the Monarch II cartridge whic
| Date | Sep 23, 2008 (initiated Jul 7, 2008) |
| Status | Terminated |
| Reason | Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens. |
| Root cause | Mixed-up of materials/components |
| Action | 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. |
| Quantity | 7962 units |
| Distribution | Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001157 | MONARCH II IOL DELIVERY SYSTEM Alcon Research, Ltd., Jun 27, 2000 |