Recall Z-0542-2014
CooperVision Inc. · initiated November 20, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses
Codes / lots: Lot 361950571720, potential incorrect expiry date 1/2018; Lot 361950575934, potential incorrect expiry date 9/2017; Lot 361950589008, potential incorrect expiry date 2/2018; Lot 361950590915, potential incorrect expiry date 8/2018; Lot 361950597210, potential incorrect expiry date 7/2017; Lot 361950599011, potential incorrect expiry date 8/2018; Lot 361950599816, potential incorrect expiry date 9/2017; Lot 361950606714, potential incorrect expiry date 12/2017; Lot 361950608721, potential incorrect expiry date 6/2018; Lot 361950613813, potential incorrect expiry date 1/2018; Lot 361950632507, potential incorrect expiry date 3/2018; Lot 361950638202, potential incorrect expiry date 2/2017; Lot 361950644719, potential incorrect expiry date 10/2018; Lot 361950646326, potential incorrect expiry date 10/2018; Lot 361950647128, potential incorrect expiry date 10/2018; Lot 361950676608, potential incorrect expiry date 12/2018; Lot 361950682615, potential incorrect expiry date 10/2017; Lot 361950684220, potential incorrect expiry date 10/2019; Lot 361950691505, potential incorrect expiry date 1/2017; Lot 361950692806, potential incorrect expiry date 7/2018; Lot 361950706108, potential…
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.
FDA-determined cause: Incorrect or no 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.
Details
- Recall number
- Z-0542-2014
- Initiated
- November 20, 2013
- Posted by FDA
- December 19, 2013
- Terminated
- July 22, 2015
- Product code
- MVN – Lens, Contact, (Disposable)
- Quantity
- 153 cartons
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
- Recalling firm
- CooperVision Inc., W Henrietta, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0543-2014 Class II | ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for…Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package… | 11/20/2013Terminated |