Recall Z-0543-2014— CooperVision Inc.

Name: FDA recall Z-0543-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-20

Class II · Terminated

Class II FDA medical device recall by CooperVision Inc., initiated 2013-11-20, terminated 2015-07-22. It names one FDA 510(k) clearance: K091339. 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: Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date..

Recalling firm: CooperVision Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-20
Terminated: 2015-07-22
Firm location: W Henrietta, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K091339 — BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSCooperVision, Inc.·cleared 2010-01-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.