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Terminated

TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

FDA Recall Z-0237-2016 · Posted 2015-11-06

Recalling FirmTekia, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2015-09-29
Date Terminated2015-12-03
Product Quantity50 units

Reason for Recall

Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Internationally to Vietnam.

Official Source

View FDA Recall →

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

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