FDA Medical Device Recalls (openFDA)
Tekia, Inc.: TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
- Recall number
- Z-0694-2020
- Recalling firm
- Tekia, Inc.
- Product
- TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
- Status
- Terminated
- Initiated
- 2018-11-09
- Posted
- not on file
- Terminated
- 2020-09-16
- Reason
- A limited number of lenses may be mislabeled with the incorrect diopter power.
- Root cause
- Process control
- Action
- The recalling firm issued letters dated 11/9/2018 notifying the consignee to take the following actions: 1) to stop using the device and remove the product from inventory, 2) inform TEKIA by email (sahil@tekia.com, pascale@tekia.com) within 3 working days of all the retrieved and already implanted Single Piece Hydrophilic Acrylic IOLs listed in the letter, including serial numbers, and 3) destroy the product once every affected IOL is removed out from your inventory and forward evidence of destruction with corresponding serial numbers by email (sahil@tekia.com, pascale@tekia.com). If you have any questions, please contact a TEKIA Customer Service or QA Representative at (949)-699-1300.
- Quantity
- 81 IOLs were distributed but only 36 within expiry were recalled
- Distribution
- There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.
- Lot, serial or model codes
- 36 recalled serial numbers from Lot 522-003: U12220229, U12220230, U12220231, U12220232, U12220233, U12220234, U12220235, U12220236, U12220237, V01110221, V01110222, V01110223, V01110224, V02200066, V02200067, V02200068, V02200069, V02200070, V02200071, V03190037, V03190038, V04090143, V04090144, V04090145, V04090146, V04090147, V04090148, V04090149, V04090150, V04090151, V04090152, V01080056, V01080057, V03290055, V03290056, and V05020831. The remaining 45 IOL serial numbers were past expiry and not recalled.
- 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