Optimedica Corporation recalls Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 Th…

Recall date

February 20, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1683-2015

FDA classification

Class II

Brand / firm

Optimedica Corporation

Sold / distributed

Worldwide Distribution - US Nationwide, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Brazil, Italy, Belgium, Egypt, Colombia, Hong Kong, and Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.