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U.S. Department of Health and Human Services

Class 2 Device Recall TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0

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 Class 2 Device Recall TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0see related information
Date Initiated by FirmNovember 09, 2018
Create DateDecember 17, 2019
Recall Status1 Terminated 3 on September 16, 2020
Recall NumberZ-0694-2020
Recall Event ID 83903
Product Classification intraocular lens - Product Code HQL
ProductTEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
Code Information 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. 
Recalling Firm/
Manufacturer		 Tekia, Inc.
17 Hammond Ste 414
Irvine CA 92618-1635
For Additional Information ContactMr. Gene Currie
949-699-1300
Manufacturer Reason
for Recall		A limited number of lenses may be mislabeled with the incorrect diopter power.
FDA Determined
Cause 2		Process control
ActionThe 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 in Commerce81 IOLs were distributed but only 36 within expiry were recalled
DistributionThere was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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