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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES ALCON ALLEGRETTO WAVELIGHT 400 EXCIMER LASER

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ALCON LABORATORIES ALCON ALLEGRETTO WAVELIGHT 400 EXCIMER LASER Back to Search Results
Model Number 400
Event Date 05/29/2009
Event Type  Injury  
Event Description

Bilateral lasik with wavelight 400 excimer laser. Uncomplicated treatment and permanent night vision blur, not responsive to miotics not spectacles with anti-glare coating. No significant refractive error, not a large pupil. Debilitating night vision, cannot drive at night. Significant wavefront errors on wavefront mapping. Low spherical aberrations, but high coma and trefoil wavefront aberrations following wavelight custom adjusted treatment. Pre op refraction: od -2. 75 - 0. 75 x 169 os - 2. 75 - 0. 75 x 17 scotopic pupil: od 7. 98 os 7. 67 post op refraction: od plano - 0. 44 x 140 os plano - 0. 21 x 45 uncorrected va: od 20/20, os 20/15. Diagnosis or reason for use: myopia and astigmatism.

 
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Brand NameALCON ALLEGRETTO WAVELIGHT 400 EXCIMER LASER
Type of DeviceLASER
Manufacturer (Section D)
ALCON LABORATORIES
ft. worth TX
MDR Report Key2345348
Report NumberMW5023171
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 11/16/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number400
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/05/2009
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 11/16/2011 Patient Sequence Number: 1
Treatment
BILATERAL LASIK
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