Optimedica Catalys Precision Laser System Recalled for Transformer Heating Risk

Plain-English summary

Optimedica Corporation is recalling 78 units of the Catalys Precision Laser System, including 39 units in the United States and 39 units internationally. The affected devices are indicated for use in patients undergoing cataract surgery for the removal of the crystalline lens. The recall covers all units shipped prior to October 18, 2013.

The recall is being conducted because of a potential for unexpected heating of the transformer mounting bolt located within the system chassis. This heating may cause the subsequent melting of a non-slip computer shelf mat, which can manifest as an odor and visible smoke.

The affected units were distributed worldwide, including in the United States and in countries such as Germany, Switzerland, Australia, Spain, Japan, the United Kingdom, Canada, France, The Netherlands, Austria, Singapore, and the Dominican Republic. Consumers and healthcare providers should stop using the affected devices and contact Optimedica Corporation for further instructions.

The recalled product

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

Manufacturer

Optimedica Corporation

Category

Medical Device — Surgical Equipment

Hazard

• fire
• smoke

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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