Reported Aug 17, 2016 · Terminated
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation…
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?
- OpthalmicPASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally
- Lot codes and dates
- Model PASCAL Synthesis (532/577)
- Serial numbersUnited
- States
7905621579064615770554147906571579088615790884157906311579081015790958167908571577050213770503137705211377052913790889167908161577051913770523137705311379071415790738157705361379081515
- ROW
182 of 182 codes
790879157907371579074915790754157907551579076315790765157907671579076915770557147905031479050614790507147905091479051114790512147905141479051714790521147905221479052314790527147905281479052914790530147905321479053314790540147905411479054214790544147905471479054814790550147905531479055414790557157905791579058015790581157905821579059715790598157906431579065115790652157906541579065915790675157906761579067715790680157906811579068715790699157907051579071115790724157907261579072715
- Amount recalled
- 205 units (21 in US, 184 OUS)
Where it was sold
- Nationwide
Why it was recalled
Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode.
This product could cause temporary or reversible health problems — stop using it.
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