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U.S. Department of Health and Human Services

Class 2 Device Recall IOL Master 5.5

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  Class 2 Device Recall IOL Master 5.5 see related information
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 K993357  K101182  K122418  
Product Classification Biomicroscope, slit-lamp, ac-powered - Product Code HJO
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
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
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.
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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