Recall Z-2441-2008
Alcon Laboratories, Inc · initiated July 7, 2008
Product
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 which can be visually verified prior to use.
Codes / lots: Lot 174249 Exp 07/2010 Lot 174250 Exp 07/2010 and Lot 174244 Exp 07/2010
Reason for recall
Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.
FDA-determined cause: Mixed-up of materials/components
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.
Details
- Recall number
- Z-2441-2008
- Initiated
- July 7, 2008
- Posted by FDA
- September 23, 2008
- Terminated
- August 26, 2009
- Product code
- KYB – Lens, Guide, Intraocular
- Quantity
- 7962 units
- Distribution
- Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
- Recalling firm
- Alcon Laboratories, Inc, Fort Worth, TX