PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
FDA Recall Z-1774-2013 · Posted 2013-07-19
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Recalling FirmTopcon Medical Laser Systems, Inc
Recall StatusTerminated
Product CodeHQF
Date Initiated2012-03-27
Date Terminated2013-07-19
Product Quantity7 US, 33 foreign
Reason for Recall
When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
Firm Action
Initial notification was sent on March 27, 2012 to all TMLS Distribution Partners and Sales Representative. This was followed by a follow up notification on June 4, 2012. A final notice was sent on February 11, 2013 to all those who had not sent documentation that the field action had been implemented.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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