Z-0529-2015 Class II Terminated

Recalled by Cooper Vision Caribbean Corp. — Juana Diaz, PR

FDA device recall Z-0529-2015 was initiated by Cooper Vision Caribbean Corp. on October 28, 2014 and is designated Class II. Reason for recall: Portions of the lots may contain units with an incorrect lens axis condition. The recall status is terminated (terminated October 2, 2015). Affected quantity: 1170.

Recall Details

Product Type
Devices
Report Date
December 17, 2014
Initiation Date
October 28, 2014
Termination Date
October 2, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1170

Product Description

Soft Contact Lens

Reason for Recall

Portions of the lots may contain units with an incorrect lens axis condition.

Distribution Pattern

US Nationwide Distribution.

Code Information

Lots # 8246525202 & 8255525096