Reported Jul 31, 2013 · Terminated
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Topcon Medical Laser Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Topcon Medical Laser Systems, Inc · 3130 Coronado Dr · Santa Clara, CA · 95054-3205
Is this the product you have?
- PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
- Lot codes and dates
- PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x
- x Serial numbersUnited States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States.
OMC-1791113850911141209111472091114780911148910111490101114921011149710
1 151110 11151211 33054310 33059310 33059510 33062810" 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 660852111114981011150110111502101115041011150610111508101115091011151010
- Amount recalled
- 7 US, 33 foreign
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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