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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLEGRETTO WAVE EYE-Q EXCIMER LASER ALLEGRETTO WAVE EYE-Q EXCIMER LASER WAVEFRONT LASIK

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ALLEGRETTO WAVE EYE-Q EXCIMER LASER ALLEGRETTO WAVE EYE-Q EXCIMER LASER WAVEFRONT LASIK Back to Search Results
Event Date 10/21/2010
Event Type  Injury  
Event Description

I had lasik twice now. The first time on (b)(6) 2010. As a result of lasik, i had the following complications: overcorrection which caused me constant strain and pain -severe loss of near sight due to overcorrection -extreme starbursts and halos at night -loss of vision in dim settings which also caused my eyes to strain -daily pain and discomfort and pressure in brow area -constant blood shot eyes. I underwent the enhancement on (b)(6) 2010. While it seem to have helped with some issues, i still have: daily strain -severe starbursts and halos at night -loss of vision in dim settings. This still causes my eyes to strain and i feel daily pressure in my brow area. I also feel pain in my left eye. It is difficult to drive at dusk and night. My pupils are very large and i was never informed about pupil size. Nor were my eyes ever dilated. I know this is a problem as most of my issues are at night and in dim lighting. Lasik is not safe.

 
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Brand NameALLEGRETTO WAVE EYE-Q EXCIMER LASER
Type of DeviceWAVEFRONT LASIK
Manufacturer (Section D)
ALLEGRETTO WAVE EYE-Q EXCIMER LASER
MDR Report Key1916830
Report NumberMW5018390
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/26/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 11/26/2010 Patient Sequence Number: 1
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