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

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Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.