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Terminated

TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.

FDA Recall Z-0694-2020 · Posted None

Recalling FirmTekia, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2018-11-09
Date Terminated2020-09-16
Product Quantity81 IOLs were distributed but only 36 within expiry were recalled

Reason for Recall

A limited number of lenses may be mislabeled with the incorrect diopter power.

Firm 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 ([email protected], [email protected]) 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 ([email protected], [email protected]). If you have any questions, please contact a TEKIA Customer Service or QA Representative at (949)-699-1300.

Root Cause

Process control

Distribution Pattern

There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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