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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLEGRETTO WAVELIGHT ALLEGRETTO WAVELIGHT, LASIK

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ALLEGRETTO WAVELIGHT ALLEGRETTO WAVELIGHT, LASIK Back to Search Results
Event Date 05/10/2009
Event Type  Injury  
Event Description

I was under educated about the lasik procedure and now have severe dry eye that is not getting better as well as horrible night vision that makes it so that i do not feel safe driving a car at night. Date of use: 2009. Diagnosis: myopia, astigmatism.

 
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Brand NameALLEGRETTO WAVELIGHT
Type of DeviceALLEGRETTO WAVELIGHT, LASIK
MDR Report Key1513545
Report NumberMW5013098
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/16/2009
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/16/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 10/16/2009 Patient Sequence Number: 1
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