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U.S. Department of Health and Human Services

Class 2 Device Recall IOLMaster 500

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 Class 2 Recall
IOLMaster 500
see related information
Date Posted November 15, 2013
Recall Status1 Open
Recall Number Z-0334-2014
Recall Event ID 66635
Premarket Notification
510(K) Numbers
K101182  K122418  K993357 
Product Classification Biomicroscope, Slit-Lamp, Ac-Powered - Product Code HJO
Product Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
Code Information Serial Numbers: 817123 1038929 1038930 1044483 1044485 1044487 1044488 1044489 1044490 1045639 1046055 1046056 1046057 1046343 1046344 1046345 1046353 1046355 1046364 1046373 1046374 1046376 1046377 1046378 1046380 1046381 1046488 1046489 1046500 1046509 1046514 1046516 1046523 1047089 1047090 1047091 1047092 1047093 1047101 1047107 1047111 1047266 1047267 1047268 1047269 1047270 1047271 1047272 1047273 1047275 1047279 1047282 1047283 1047284 1047485 1047486 1047494 1047498 1047499 1047507 1047512 1047513 1047518 1047519 1047520 1047521 1047522 1047523 1047524 1047914 1047921 1047922 1047923 1047924 1047933 1047934 1047935 1047936 1047938 1048579 1048580 1048581 1048582 1048583 1048584 1048585 1048587 1048589 1049601 1049602 1049603 1049604 1049605 1049607 1049608 1049609 1049610 1049611 1049620 1049621 1049622 1050560 1050561 1050562 1050563 1050564 1050566 1050567 1050568 1050569 1050748 1050749 1050751 1050752 1050753 1050754 1050755 1050756 1050757 1050758 1050759 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Recalling Firm/
Manufacturer
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr
Dublin, California 94568-7562
For Additional Information Contact Judith A. Brimacombe, M.A.
925-557-4616
Manufacturer 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.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software in the Use Environment
Action 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.
Quantity in Commerce 1,201 units
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HJO and Original Applicant = CARL ZEISS MEDITEC AG
510(K)s with Product Code = HJO and Original Applicant = CARL ZEISS, INC.
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