Cl II Carl Zeiss IOL Master 5.5

Company:.Carl Zeiss Meditec AG.
Date of Enforcement Report 12/9/2015
Class lI:

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. Recall Number Z-0357-2016

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

RECALLING FIRM/MANUFACTURER
Carl Zeiss Meditec AG, Jena, DE on 10/27/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
49

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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Partners located in the US (CA, FL, MA, MN) and Italy.