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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description 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
Recall Number Z-0543-2014
Classification Class II
Code Info 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.
Product Distributed Qty 45 cartons
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.

Event Detail

Event Id 66844
Product Type Devices
Status Ongoing
Recalling Firm CooperVision Inc.
City W Henrietta
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
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