Recall Z-0044-2012 ยท LPL Lenses, Soft Contact, Daily Wear
CooperVision Inc.
AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00-
| Date | Oct 14, 2011 (initiated Aug 19, 2011) |
| Status | Terminated |
| Reason | This recall was initiated because of the unintended presence of a residue (silicone oil) on lenses from certain lots of Avaira Toric contact lenses. The company received complaints of temporary hazy or blurry vision and discomfort, most likely caused by transient or reversible swelling of the surface layer of the cornea, which is known as corneal epithelial edema. Corneal epithelial edema results when there is insufficient oxygen to the eye, which may be caused by the presence of residue on the lens. Through laboratory testing and investigation, the company determined the cause of the cornea |
| Root cause | Material/Component Contamination |
| Action | The firm, CooperVision sent an "Urgent: Company Initiated Voluntary Medical Device Recall - Contact Lenses" notification letter to all affected consignees. The notice identified the product, the problem, and the actions to be taken. The letter includes an attached "Recall Response Form" that consignees are required to complete and fax to (585) 889-5688. Consignees were instructed to immediately examine their inventory, stop any further distribution, quarantine and return product subject to recall. In addition, consignees were told if they have further distributed the affected product to n |
| Quantity | At least ( 778,301 lenses: Domestic - 659,847 lenses; Foreign - 118,454 lenses; including EXPANSION: Domestic - 69,047 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Europe, Germany, Hong Kong, Italy, New Zealand, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071736 | AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CooperVision, Inc., Jan 4, 2008 |