Recall Z-0631-2013— Cooper Vision Caribbean Corp.

Name: FDA recall Z-0631-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-09

Class II · Terminated

Class II FDA medical device recall by Cooper Vision Caribbean Corp., initiated 2012-11-09, terminated 2014-05-09. It names one FDA 510(k) clearance: K113759. Product: AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses. Reason: The lenses exceeded the acceptance limit for silicone oil residual..

Recalling firm: Cooper Vision Caribbean Corp.
Classification: Class II
Status: Terminated
Initiated: 2012-11-09
Terminated: 2014-05-09
Firm location: Juana Diaz, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K113759 — AVAIRA (ENFILCON A) CONTACT LENSCooperVision, Inc.·cleared 2012-04-03

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

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

Reason for recall

The lenses exceeded the acceptance limit for silicone oil residual.

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