FDA Medical Device Recalls (openFDA)
Cooper Vision Caribbean Corp.: AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
- Recall number
- Z-0631-2013
- Recalling firm
- Cooper Vision Caribbean Corp.
- Product
- AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
- Status
- Terminated
- Initiated
- 2012-11-09
- Posted
- 2013-01-03
- Terminated
- 2014-05-09
- Reason
- The lenses exceeded the acceptance limit for silicone oil residual.
- 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
- 246
- Distribution
- US Nationwide, including Puerto Rico, and Canada.
- Lot, serial or model codes
- 10447500016006, 10519550007006, 10537500016014
- 510(k) numbers
- ["K113759"]
- PMA numbers
- not on file
- Product code
- LPL
- Firm FEI
- 3002911336
- Firm city
- Juana Diaz
- Firm state
- not on file
- Firm country
- PR
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28