Reported Dec 9, 2015 · Terminated

IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of…

Carl Zeiss Meditec AG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Carl Zeiss Meditec AG · Carl Zeiss Promenade 10 · Jena · N/A

Is this the product you have?

  • IOL Master 500Software versions 7.5 and 7.7
  • OphthalmicIOL Master 500 is intended for 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
Lot codes and dates
  • Softwre versions 7.5 and 7.7
  • serial numbers

    1,986 of 1,986 codes

    • 1040306
    • 1045450
    • 1035312
    • 1034011
    • 1035310
    • 1043145
    • 1039588
    • 1130284
    • 1077017
    • 1075278
    • 1063476
    • 1058047
    • 1063472
    • 1081152
    • 1119831
    • 1124952
    • 1059878
    • 1090593
    • 1054367
    • 1058611
    • 1080034
    • 1090586
    • 1132460
    • 1095841
    • 1095836
    • 1066448
    • 1097694
    • 1132525
    • 1105634
    • 1130344
    • 1126762
    • 1055245
    • 1059877
    • 1086809
    • 1053566
    • 1101702
    • 1092639
    • 1057182
    • 1095824
    • 1083506
    • 1119231
    • 1126790
    • 1065670
    • 1063475
    • 1081192
    • 1075271
    • 1117159
    • 1098299
    • 1139278
    • 1083484
    • 1132509
    • 1145130
    • 1092692
    • 1115088
    • 1124953
    • 1126802
    • 1052948
    • 1125668
    • 1082378
    • 1120161
Amount recalled
1882

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 6, 2016 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.