Topcon Recalls PASCAL Synthesis Ophthalmic Laser Systems Due to Titration Anomaly
Topcon Medical Laser Systems is recalling 205 PASCAL Synthesis ophthalmic laser systems worldwide due to a software anomaly affecting the titration process when specific functions are used.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths. The hazard is a functional anomaly in the device's operation rather than a direct physical injury risk, fitting the criteria for a moderate severity rating.
Plain-English summary
Topcon Medical Laser Systems, Inc. is recalling 205 units of the PASCAL Synthesis ophthalmic scanning laser system. The recall covers 21 units in the United States and 184 units distributed in other countries, including Canada, Mexico, Japan, and the United Kingdom.
The recall was initiated after Topcon discovered an anomaly with the titration process. This issue occurs only when the EpM function is turned on during titration. Specifically, the event may happen if a user turns on EpM, turns off the Landmark (LM) function while using an EpM-supported pattern, and then enters titration mode.
The source text does not report any illnesses, injuries, or deaths associated with this anomaly. Users of the affected devices should contact Topcon Medical Laser Systems for instructions on how to resolve the issue.
The recalled product
- Product
- Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
- Manufacturer
- Topcon Medical Laser Systems, Inc
- Hazard
Distribution
Distributed nationwide across the United States.
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