Recall Z-0129-2011 ยท LPN Accessories, Soft Lens Products
Abbott Medical Optics Inc (AMO)
AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
| Date | Nov 2, 2010 (initiated Jul 23, 2010) |
| Status | Terminated |
| Reason | The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening. |
| Root cause | Pending |
| Action | AMO prepared and issued on July 28, 2010 both a customer and distributor notification letter as part of their customer communication process. The letter informed the customers of the reason for recall, the products involved, the hazard involved and actions to be taken regarding the affected products. Customer with questions related to the COMPLETE Multi-Purpose Solution and/or Total Care (1) Contact Lens Solution return process, were instructed to contact an AMO Customer Service Representative at 1800 931 663. |
| Quantity | 34,080 units |
| Distribution | International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014202 | COMPLETE BRAND MULTI-PURPOSE SOLUTION Allergan, Inc., Feb 20, 2002 |