ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- Coope

FDA device recall Z-0543-2014 · posted 2013-12-19 · Terminated

Recall details

Recalling firm

CooperVision Inc.

Reason for recall

Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.

Action taken

CooperVision sent an Urgent Medical Device Recall Letters dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Our records indicate you received some of the affected product. Enclosed you will find a list of affected carton lot numbers, with the correct expiration date, that were shipped to your account. " Please immediately examine your inventory, " Stop any further distribution of carton(s) subject to the recall, " Quarantine carton(s) with incorrect expiration date, and " CooperVision will make arrangements to remove affected, quarantine product. As soon as possible, please complete the attached response form and fax it to 1.866.484.1048 or scan and email to info@coopervision.com. If you have product to return please contact customer service for instructions and to schedule pick-up and removal of affected, quarantined product. Your account will be credited once the product is returned and processed. We appreciate your assistance and apologize for any inconvenience you or your patients experienced by this removal. If you have any further questions, please feel free to contact us at 800-341-2020.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

MVN

Quantity affected

45 cartons

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.

Date initiated

2013-11-20

Date posted

2013-12-19

Date terminated

2015-07-22

Location

W Henrietta, NY

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