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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT GMBH (PRESSATH) ALLEGRETTO WAVE; EXCIMER LASER SYSTEM

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WAVELIGHT GMBH (PRESSATH) ALLEGRETTO WAVE; EXCIMER LASER SYSTEM Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dry Eye(s) (1814); Emotional Changes (1831); Eye Injury (1845); Pain (1994); Visual Impairment (2138)
Event Date 02/03/2021
Event Type  Injury  
Event Description
Permanently impaired vision; i had lasik and was promised it was a safe and harmless procedure.I now use (b)(6) of eye drop a month to survive, need all instant medical attention, have a constantly changing prescription, corneal chronic pain and dryers.It was destroyed my quality of life and my mental well-being.Lasik is hands down the worst thing that has ever happened to me.And i was a perfect candidate and went to a top doctor.My eyes had no problems before.I didn't even need eye drops.No my day centers around eye drops.I've met hundreds in my same situation.Something needs to be done.Exonerated laser wave tech allegretto.Fda safety report id# (b)(4).
 
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Brand Name
ALLEGRETTO WAVE
Type of Device
EXCIMER LASER SYSTEM
Manufacturer (Section D)
WAVELIGHT GMBH (PRESSATH)
MDR Report Key12467101
MDR Text Key271530474
Report NumberMW5103892
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/13/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age37 YR
Patient Weight59
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