Recall Z-0334-2014
Carl Zeiss Meditec, Inc. · initiated October 23, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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 1050760 1050761 1050762 1050763 1051518 1051519 1051520 1051521 1051522 1051523 1051524 1051525 1051526 1051527 1051528 1051529 1051530 1051531 1051533 1051534 1051536 1051538 1051550 1051551 1051552 1051553 1051554…
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: Software in the Use Environment
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.
Details
- Recall number
- Z-0334-2014
- Initiated
- October 23, 2013
- Posted by FDA
- November 15, 2013
- Terminated
- April 17, 2014
- Product code
- HJO – Biomicroscope, Slit-Lamp, Ac-Powered
- Quantity
- 1,201 units
- Distribution
- Nationwide distribution.
- Recalling firm
- Carl Zeiss Meditec, Inc., Dublin, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0333-2014 Class II | Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is…The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the… | 10/23/2013Terminated |