WAVELIGHT EX500 EXCIMER LASER
Received Jul 17, 2026 · Event occurred Jun 19, 2026
Report 3003288808-2026-00307 · MDR key 25855145
Device
Generic name
Ophthalmic Excimer Laser System
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065998287
Lot number
17UPD2
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
34 YR · Unknown
- Blurred Vision
- Visual Impairment
Narrative
Additional Manufacturer Narrative
H.6: INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
THE PHYSICIAN REPORTED THAT THERE WAS AN OVERCORRECTION IN THE LEFT EYE, AND THE PATIENT COMPLAINED OF BLURRY VISION ONE WEEK AFTER THE PROCEDURE. HOWEVER, THE RIGHT EYE WAS DOING PERFECTLY WELL WITH VISUAL ACUITY. AS PER THE SURGEON, THE LEFT EYE WAS OVERCORRECTED, AND THE CURRENT VISUAL ACUITY WAS MORE THAN TWO LINES AFTER THE REFRACTIVE SURGERY.