Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec

FDA device recall Z-0333-2014 · posted 2013-11-15 · Terminated

Recall details

Recalling firm: Carl Zeiss Meditec, Inc.
Reason for recall: The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.
Action taken: The firm, Zeiss, sent an "Urgent Medical Device Correction" letter dated October 23, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to immediately update the Laser Interference Biometry (ULIB) lens constants, provided as an Attachment 1 and complete and return Attachment 2- Confirmation Form via mail to: Stericycle, Inc., 6026 Lakeside Blvd., Indianapolis, IN 46278; Attn: Zeiss IOLMaster. If you have any questions, call the following number for assistance: 1 (866) 891-1922.
Root cause: Software in the Use Environment
Status: Terminated
Product code: HJO
Quantity affected: 4,907 units
Distribution: Nationwide distribution.
Date initiated: 2013-10-23
Date posted: 2013-11-15
Date terminated: 2014-04-17
Location: Dublin, CA

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