Z-0631-2013Class II

AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses

Name: Z-0631-2013 AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Creator: Cooper Vision Caribbean Corp.
Published: 2012-11-09
License: https://open.fda.gov/license/

COOPERVISION Manufacturing Puerto Rico, LLC / initiated 2012-11-09 / Terminated / root cause: manufacturing process

FDA source

Cooper Vision Caribbean Corp. began a recall of AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses on 2012-11-09. FDA classified it as Class II and gives the reason as "The lenses exceeded the acceptance limit for silicone oil residual". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0631-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-09
Posted: 2013-01-03
Terminated: 2014-05-09
Recalling firm: COOPERVISION Manufacturing Puerto Rico, LLC
Product: AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: The lenses exceeded the acceptance limit for silicone oil residual.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The recall was conducted to the wholesale/distributor and Eye Care Practitioner level. The company contacted the Authorized Distributors by telephone, followed by written notification dated November 9, 2012. All written notifications to first consignees, for both revenue and Fit Sets, were sent by overnight mail with signature required as proof of receipt and the envelopes were marked "Urgent". The notifications described the issue and provided recommended actions. Customers may contact 800-341-2020 if questions.
Quantity in commerce: 246
Distribution: US Nationwide, including Puerto Rico, and Canada.
Product codes and lots: 10447500016006, 10519550007006, 10537500016014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0631-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0631-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-09	2013-01-03

Product code LPL

K113759Class IIAvaira (Enfilcon a) Contact LensCooperVision, Inc. / cleared 2012-04-03

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)