Data Foundry

Medical device recalls 2013

Pro clear — Class II medical device recall Z-0542-2014

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-0542-2014
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
Quantity153 cartons
Reason classeslabeling
UPC / GTIN / UDI-DI00361950571720, 00361950589008, 00361950599816, 00361950647128, 00361950706108, 00361950829333
Lot numbers361950575934, 361950590915, 361950597210, 361950599011, 361950606714, 361950608721, 361950613813, 361950632507, 361950638202, 361950644719, 361950646326, 361950676608, 361950682615, 361950684220, 361950691505, 361950692806, 361950706308, 361950711903, 361950712707, 361950742714, 361950744516, 361950767118, 361950778620, 361950789608, 361950800811, 361950826215, 361950839008, 361950845916, 361950859017, 361950863106, 361950894913, 361950912828, 361950919611, 361950919914, 361950937619, 361950955510, 361950955610, 361950971611, 361950972311, 361951007612 and 4 more
Expiration dates2013-07, 2015-01, 2017-01, 2017-02, 2017-03, 2017-04, 2017-07, 2017-09, 2017-10, 2017-12, 2018-01, 2018-02, 2018-03, 2018-04, 2018-05, 2018-06, 2018-07, 2018-08, 2018-10, 2018-12, 2019-10

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

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-0542-2014. 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.