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

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).

• Brand Name: WAVELIGHT EX500
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): ALCON / WAVELIGHT GMBH
• MDR Report Key: 12173076
• MDR Text Key: 261910123
• Report Number: MW5102540
• Device Sequence Number: 1
• Product Code: LZS
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 68