Agency classClass IIOur severity:High FDA (Devices)·Z-0649-2014·Announced 2014-01-15

Optimedica Catalys Precision Laser System Recalled for Transformer Heating Risk

Optimedica is recalling 78 Catalys Precision Laser Systems worldwide due to a risk of transformer heating and smoke.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of fire and smoke from a medical device, which constitutes a risk-of-harm product where injury has not yet been reported, aligning with the High severity criteria.

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…
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.

Lot numbers (20)

All units shipped prior to Octotber 18
2013. US Serial numbers: 44055311
44055611
44055811
44056012
44056312
44056612
44056712
44056812
44057312
44057812
44058012
44058212
44058312
44059212
44059312
44059612
44059712
44059812
44059912

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Same manufacturer · Optimedica Corporation

See all →

High
OptiMedica Catalys Precision Laser System Software Recall for Incorrect Parameters
FDA (Devices) · 2015-06-03

Same hazard · fire