Date Initiated by Firm | October 27, 2015 |
Date Posted | December 01, 2015 |
Recall Status1 |
Terminated 3 on June 06, 2016 |
Recall Number | Z-0357-2016 |
Recall Event ID |
72564 |
510(K)Number | K101182 K122418 K993357 |
Product Classification |
Biomicroscope, slit-lamp, ac-powered - Product Code HJO
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Product | IOL Master 5.5: Software versions 7.5 and 7.7;
Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation. |
Code Information |
Software versions 7.5 and 7.7: Serial numbers: 1040306 1045450 1035312 1034011 1035310 1043145 1039588 1041805 1040321 1041803 1045443 1036716 1035318 1038800 1034016 1041838 1041833 1039587 1035291 1040313 1038795 1034051 1036553 1040314 1036539 1036702 1043952 1039614 1036541 1043121 1036786 1036713 1045455 1034801 1034792 1034071 1043117 1034795 1045451 1039611 1043941 1036693 1041836 1036532 1043132 1043134 1034073 1034822 1040315. |
Recalling Firm/ Manufacturer |
Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany
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For Additional Information Contact | Judith A. Brimacombe, M.A. 925-557-4616 |
Manufacturer Reason for Recall | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. |
FDA Determined Cause 2 | Software design |
Action | Urgent Medical Device Correction letters will be mailed on Friday, November 13, 2015 as the IOL SW update material is now available. Letter informs customers of the issue and provide instructions for identifying the software version and for installing the software update with illustrations.
All customers are requested to complete and return the confirmation form to Stericycle as soon as the upgrade is complete or it has been determined that your unit is not running the affected version of the software. |
Quantity in Commerce | 49 |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = HJO 510(K)s with Product Code = HJO
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