ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2

FDA device recall Z-0134-2015 · posted 2014-10-24 · Terminated

Recall details

Recalling firm

Cooper Vision Caribbean Corp.

Reason for recall

Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.

Action taken

The firm sent out a notification letter with the following instructions: Please take the following actions immediately: " Examine your inventory for any affected lot numbers o Use the enclosed report to inspect your inventory for affected product that is still in your Warehouse. " Stop any further distribution of the specified lots of Preclear T oric lenses. " Quarantine any Preclear Toric lenses with the specified lot numbers. " Within the next five (5) business days, please complete the attached Recall Response Form and fax it to 866-484-1048 or scan and email to info@coopervision.com. o If you have indicated that you have product to return, you will be contacted by a CooperVision Representative with instructions for pick-up and removal of affected, quarantined product. Your account will be credited once the product is returned and processed. This action is being taken in full cooperation with the Food and Drug Administration (FDA). The recall only affects Proclear T oric lenses with the lot numbers specified on the enclosed list. No other Preclear T oric products- or any other CooperVision products - are affected.

Root cause

Other

Status

Terminated

Product code

LPL

Quantity affected

13639 lenses/246 product lots

Distribution

Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries.

Date initiated

2014-09-17

Date posted

2014-10-24

Date terminated

2015-06-10

Location

Juana Diaz, PR

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