FDA Medical Device Recalls (openFDA)
Tekia, Inc.: TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
- Recall number
- Z-0237-2016
- Recalling firm
- Tekia, Inc.
- Product
- TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
- Status
- Terminated
- Initiated
- 2015-09-29
- Posted
- 2015-11-06
- Terminated
- 2015-12-03
- Reason
- Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
- Root cause
- Error in labeling
- Action
- Tekia sent an Field Safety Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were advised that Tekia is recalling a limited a number of Single Piece Hydrophilic Acrylic IOLs. If the customer has any questions, the customer is instructed to contact a TEKIA Customer Service or QA Representative at (949) 699-1300. Customers with product complaints or adverse events regarding the use of Single Piece Hydrophilic Acrylic IOLs are instructed to inform TEKIA by phone, email, or fax.
- Quantity
- 50 units
- Distribution
- Internationally to Vietnam.
- Lot, serial or model codes
- SN: U07310001 thru U07310040 , 07310050 thru U07310059
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HQL
- Firm FEI
- 3002023310
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
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