Topcon PASCAL Laser Recall Due to Power Mismatch Risk
Topcon Medical Laser Systems is recalling PASCAL and PASCAL Streamline lasers because a software function may cause power output mismatches, leading to over or under treatment.
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-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Topcon Medical Laser Systems, Inc. is recalling PASCAL and PASCAL Streamline laser systems (532 nm and 577 nm) used to treat the patient's eye. The recall involves 7 units in the United States and 33 units in foreign countries, including China, Hong Kong, Brazil, France, Japan, the Netherlands, Pakistan, Malaysia, the United Kingdom, South Korea, Thailand, Dubai, and South Africa.
The recall is due to a potential mismatch between the displayed power and the actual power output when using the "Favorites" function for saved settings. This discrepancy may result in over or under treatment of the patient's eye.
Healthcare providers should contact Topcon Medical Laser Systems, Inc. for instructions on how to address the issue. Specific serial numbers for the affected units are listed in the agency's recall record.
The recalled product
- Product
- PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
- Manufacturer
- Topcon Medical Laser Systems, Inc
Distribution
Distribution scope not specified by the agency.
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