IOL Master 5.5: Software versions 7.5 and 7.7 recallZ-0357-2016 · Carl Zeiss Meditec AG · initiated Oct 27, 2015
Class II Terminated All recalls posted in December 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carl Zeiss Meditec AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0357-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 27, 2015
- Posted by the FDA
- Dec 1, 2015
- Recalling firm
- Carl Zeiss Meditec AG
- Quantity
- 49
- Product code
- HJO
- FDA submissions
- K101182, K122418, K993357
- Distribution
- Nationwide Distribution.
Product description
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 (models, lots, serial numbers)
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.
Other devices under the same FDA submission
1 device cleared under K101182, K122418, K993357 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- IOLMaster 500Carl Zeiss Meditec AG · Biomicroscope, Slit-Lamp, Ac-Powered1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 72564).
- Z-0358-2016 · TerminatedIOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, c…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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