AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision,

FDA device recall Z-0044-2012 · posted 2011-10-14 · Terminated

Recall details

Recalling firm

CooperVision Inc.

Reason for recall

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 corneal epithelial edema was a small amount of residue (silicone oil) on the lens.

Action taken

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 notify customers at once of this product recall. The letter states that accounts will either be credited or exchanged for an unaffected product. If you have any further questions, call 1-800-341-2020.

Root cause

Material/Component Contamination

Status

Terminated

Product code

LPL

Quantity affected

At least ( 778,301 lenses: Domestic - 659,847 lenses; Foreign - 118,454 lenses; including EXPANSION: Domestic - 69,047 lenses) ( to be updated)

Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Europe, Germany, Hong Kong, Italy, New Zealand, and Spain.

Date initiated

2011-08-19

Date posted

2011-10-14

Date terminated

2019-03-06

Location

W Henrietta, NY

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