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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 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. Class II Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date. 45 cartons Z-0543-2014
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 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 incorrect expiry date 12/2018; Lot 361950706308, potential incorrect expiry date 1/2015; Lot 361950711903, potential incorrect expiry date 7/2018; Lot 361950712707, potential incorrect expiry date 2/2017; Lot 361950742714, potential incorrect expiry date 1/2017; Lot 361950744516, potential incorrect expiry date 10/2017; Lot 361950767118, potential incorrect expiry date 4/2018; Lot 361950778620, potential incorrect expiry date 1/2018; Lot 361950789608, potential incorrect expiry date 4/2018; Lot 361950800811, potential incorrect expiry date 3/2017; Lot 361950826215, potential incorrect expiry date 3/2018; Lot 361950829333, potential incorrect expiry date 9/2017; Lot 361950839008, potential incorrect expiry date 4/2017; Lot 361950845916, potential incorrect expiry date 3/2018; Lot 361950859017, potential incorrect expiry date 3/2017; Lot 361950863106, potential incorrect expiry date 9/2017; Lot 361950894913, potential incorrect expiry date 1/2018; Lot 361950912828, potential incorrect expiry date 6/2018; Lot 361950919611, potential incorrect expiry date 4/2018; Lot 361950919914, potential incorrect expiry date 4/2018; Lot 361950937619, potential incorrect expiry date 5/2018; Lot 361950955510, potential incorrect expiry date 7/2013, 8/2018; Lot 361950955610, potential incorrect expiry date 3/2018; Lot 361950971611, potential incorrect expiry date 4/2018; Lot 361950972311, potential incorrect expiry date 8/2018, 8/2013; Lot 361951007612, potential incorrect expiry date 7/2017; Lot 361951028930, potential incorrect expiry date 2/2018; Lot 361951041224, potential incorrect expiry date 2/2018; Lot 361951053705, potential incorrect expiry date 7/2018; Lot 361951057108, potential incorrect expiry date 7/2018. Class II Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date. 153 cartons Z-0542-2014
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