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Optimedica Corporation recalls Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I
Recalled January 15, 2014 · FDA recall Z-0649-2014 · Optimedica
Hazard
Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke. · FDA Class II
Units
78 (39 in US, 39 internationally)
Sold at
Worldwide Distribution: US (nationwide) including states of: TX, NC, OH, IA, UT, KY, ME, CA, NY, MA. NJ, IL, PA,, TN, FL, MO, GA, HI, SC, NE, MI, and GA and countries of: Dominican Republic, Germany, Switzerland, Australia, Spain, Japan, United Kingdom, Canada, France, The Netherlands, Austria, and Singapore.
Description
Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke.
Product
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Manufacturer(s)
Optimedica Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →