Data Foundry

Medical device recalls 2013

ClearSight — Class II medical device recall Z-0543-2014

Terminated recall by CooperVision Inc., reported 2013-12-25, distributed nationwide. Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister)

Recall numberZ-0543-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCooperVision Inc., W Henrietta, NY, United States
Recall initiated2013-11-20
Classified2013-12-19
Reported by FDA2013-12-25
Terminated2015-07-22
DistributedNationwide (US)
Countries outside the USAW, CA, CO, TT
Quantity45 cartons
Reason classeslabeling
UPC / GTIN / UDI-DI00446450110928, 00446850032905
Lot numbers446350083516, 446450173709, 446450191100, 446550083005, 446550084607, 446650162408, 446650177200, 446650178110, 446650179207, 446750082713, 446850029326, 446850129305, 446850132713, 446850133506, 447050177419, 447050181906, 447050206016
Expiration dates2016-04, 2017-01, 2017-06, 2018-02, 2018-04, 2018-06, 2019-01, 2019-02, 2019-03, 2019-05, 2019-06, 2019-07, 2019-11

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0543-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.