May

2015

Cl II Catalys Precision Laser System

Company: Optimedica Corporation
Date of Enforcement Report: 5/27/2015
Class lI:

PRODUCT

Catalys Precision Laser System-Catalys – U – US product; Catalys-1 – International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Recall Number Z-1683-2015

REASON
Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.

RECALLING FIRM/MANUFACTURER
BOptimedica Corporation, Sunnyvale, CA on 2/20/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
171

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

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.

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Cl II Catalys Precision Laser System

Amy Sellers

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