Events

Recall of IOL Master 5.5

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carl Zeiss Meditec AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72564
  • Event Risk Class
    Class 2
  • Event Number
    Z-0357-2016
  • Event Initiated Date
    2015-10-27
  • Event Date Posted
    2015-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141530
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Biomicroscope, slit-lamp, ac-powered - Product Code HJO
  • Reason
    Iol master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong iol power data.
  • 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.

Device

IOL Master 5.5
  • Model / Serial
    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.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Manufacturer
    Carl Zeiss Meditec AG

Manufacturer

Carl Zeiss Meditec AG
  • Manufacturer Address
    Carl Zeiss Meditec AG, Carl Zeiss Promenade 10, Jena Germany
  • Manufacturer Parent Company (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA