FDA Medical Device Recalls (openFDA)
Carl Zeiss Meditec AG: 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.
- Recall number
- Z-0357-2016
- Recalling firm
- Carl Zeiss Meditec AG
- 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.
- Status
- Terminated
- Initiated
- 2015-10-27
- Posted
- 2015-12-01
- Terminated
- 2016-06-06
- Reason
- IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
- Root cause
- 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
- 49
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K101182","K122418","K993357"]
- PMA numbers
- not on file
- Product code
- HJO
- Firm FEI
- 3001362763
- Firm city
- Jena
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28