U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Lens, contact, (disposable) - Product Code MVN
원인
Lots were labeled with incorrect expiration dates on secondary package (carton). the primary package (blister) is marked with the correct expiration date.
조치
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.
Lot 446350083516, potential incorrect expiry date 6/2019; Lot 446450110928, potential incorrect expiry date 2/2019; Lot 446450173709, potential incorrect expiry date 4/2018; Lot 446450191100, potential incorrect expiry date 5/2019; Lot 446550083005, potential incorrect expiry date 5/2019; Lot 446550084607, potential incorrect expiry date 2/2018; Lot 446650162408, potential incorrect expiry date 2/2018; Lot 446650177200, potential incorrect expiry date 2/2018; Lot 446650178110, potential incorrect expiry date 6/2017; Lot 446650179207, potential incorrect expiry date 6/2018; Lot 446750082713, potential incorrect expiry date 7/2019; Lot 446850029326, potential incorrect expiry date 4/2016; Lot 446850032905, potential incorrect expiry date 4/2016; Lot 446850129305, potential incorrect expiry date 1/2019; Lot 446850132713, potential incorrect expiry date 3/2019; Lot 446850133506, potential incorrect expiry date 6/2018; Lot 447050177419, potential incorrect expiry date 2/2018; Lot 447050181906, potential incorrect expiry date 1/2017; Lot 447050206016, potential incorrect expiry date 11/2019.
Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
제품 설명
ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA || daily use disposable contact lenses for astigmatism