Cl II Carl Zeiss IOL Master 500

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

PRODUCT

IOL 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, 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.
Recall Number Z-0358-2016

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
1882

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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