Z-0164-05

Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer...

Name: Z-0164-05 Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer...
Creator: 1-800 Contacts Inc.
Published: 2004-10-13
License: https://open.fda.gov/license/

1-800 Contacts Inc. / initiated 2004-10-13 / Terminated / root cause: sterility

FDA source

1-800 Contacts Inc. began a recall of Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer box reads in part: 'CooperVision proclear... on 2004-10-13. The reason FDA records is "Identified lots of Proclear Compatible contact lenses are counterfeit and may not be sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0164-05
Status: Terminated
Initiated: 2004-10-13
Posted: 2004-11-03
Terminated: 2005-02-25
Recalling firm: 1-800 Contacts Inc.
Product: Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer box reads in part: 'CooperVision proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE IN USA ** Tinted soft contact lenses *** in a buffered 0.9% saline solution***''.
Product code: MVN Lens, Contact, (Disposable)
Reason for recall: Identified lots of Proclear Compatible contact lenses are counterfeit and may not be sterile.
Root cause tag: sterility
FDA root cause: Other
Action: Identified lots of CooperVision Proclear Compatibles contact lenses are counterfeit and non-sterile.
Quantity in commerce: 82,268
Distribution: Product distributed to customers nationwide and internationally. Product distributed in US and to Canada, England, New Zealand, New Foundland, British columbia,Guam, Egypt, Greece, Japan, Ireland and Autralia.
Product codes and lots: (Identified as Lot number , power): 200218733K, -0.75; 200221583L, -1.00; 200221758L, -1.25; 200217599K, -1.50; 200219058K; -1.75; 200203444G, -2.00; 200217595K, -2.25; 200221190L, -2.50; 200219740K, -2.75; 200217588K, -3.00; 200323296A, -3.25; 200222445L, -3.50; 200325268A, -3.75; 200292234E, -4.00; 2002922484E, -4.00; 200213996J, -4.25; 200218908K, -4.50; 200214236J, -4.75; 200215709J, -5.00; 200212242J, -5.25; 200325303A, -5.50; 200213136J, -5.75; 200213135J, -6.00; 200208401H, -6.50; 200219479K, -7.00; and 200218545K, -7.50.

Product code MVN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)