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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLEGRETTO ALLEGRETTO LASIK WAVEFRONT LASER

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ALLEGRETTO ALLEGRETTO LASIK WAVEFRONT LASER Back to Search Results
Event Date 07/02/2009
Event Type  Injury  
Event Description

Despite repeated assurances that i was a "perfect" candidate for lasik via a custom wavefront "allegretto" laser, i still suffer from large starbursts and glare. The doctor and his assistants swore that i would not have these issues, yet here i am. We need the government to rein in these abuses and help people make informed choices based not on profit, but sound medicine. I had a multitude of tests and was promised this wouldn't happen with the allegretto laser. Dates of use: 2009. Diagnosis or reason for use: nearsighted. As a pt i do not know the model number of the machine - i only know it is an "allegretto wave front" laser.

 
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Brand NameALLEGRETTO
Type of DeviceLASIK WAVEFRONT LASER
Manufacturer (Section D)
ALLEGRETTO
MDR Report Key1490758
Report NumberMW5012910
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/29/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 09/29/2009 Patient Sequence Number: 1
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