Z-0543-2014Class II

ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx...

Name: Z-0543-2014 ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx...
Creator: CooperVision Inc.
Published: 2013-11-20
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2013-11-20 / Terminated / root cause: labeling and UDI

FDA source

CooperVision Inc. began a recall of ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK -... on 2013-11-20. FDA classified it as Class II and gives the reason as "Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0543-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-20
Posted: 2013-12-19
Terminated: 2015-07-22
Recalling firm: CooperVision, Inc.
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
Product code: MVN Lens, Contact, (Disposable)
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.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: CooperVision sent an Urgent Medical Device Recall Letters dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Our records indicate you received some of the affected product. Enclosed you will find a list of affected carton lot numbers, with the correct expiration date, that were shipped to your account. " Please immediately examine your inventory, " Stop any further distribution of carton(s) subject to the recall, " Quarantine carton(s) with incorrect expiration date, and " CooperVision will make arrangements to remove affected, quarantine product. As soon as possible, please complete the attached response form and fax it to 1.866.484.1048 or scan and email to [email protected]. If you have product to return please contact customer service for instructions and to schedule pick-up and removal of affected, quarantined product. Your account will be credited once the product is returned and processed. We appreciate your assistance and apologize for any inconvenience you or your patients experienced by this removal. If you have any further questions, please feel free to contact us at 800-341-2020.
Quantity in commerce: 45 cartons
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0543-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0542-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-19
Z-0543-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-19

Product code MVN

K091339Class IIBiomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. / cleared 2010-01-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)