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May 3, 2015
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...
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Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
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USA
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