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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON / WAVELIGHT GMBH WAVELIGHT EX500; EXCIMER LASER SYSTEM

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ALCON / WAVELIGHT GMBH WAVELIGHT EX500; EXCIMER LASER SYSTEM Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Inflammation (1932); Blurred Vision (2137); Halo (2227)
Event Date 07/30/2020
Event Type  malfunction  
Event Description
Had lasik surgery on (b)(6) 2020 for moderate myopia and low astigmatism by dr.(b)(6) at (b)(6).Vision has been blurry since surgery.Lasik increased my astigmatism so i needed glasses again.I now have higher order aberrations (ghosting, glare, starbursts) that are not correctable with glasses and only partially correctable with scleral lenses.My night vision used to be excellent and is now very poor.I developed dozens of dark eye floaters in both eyes 1 week after surgery.I was diagnosed with blepharitis and dry eyes that were not present before surgery.Have had only little improvement in symptoms since surgery even with prescribed treatment.Fda safety report id # (b)(4).
 
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Brand Name
WAVELIGHT EX500
Type of Device
EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON / WAVELIGHT GMBH
MDR Report Key12173076
MDR Text Key261910123
Report NumberMW5102540
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 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/14/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age27 YR
Patient Weight68
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