WAVELIGHT EX500 EXCIMER LASER
Received Jul 15, 2026 · Event occurred Jun 2, 2026
Report 3003288808-2026-00303 · MDR key 25822576
Device
Generic name
Ophthalmic Excimer Laser System
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065990713
Lot number
16H881
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
33 YR · Male
- Blurred Vision
- Visual Impairment
Narrative
Additional Manufacturer Narrative
H.3., 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
A HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED BLURRY VISION FOLLOWED BY OVERCORRECTION WHICH LOSES THE VISUAL ACUITY OF MORE THAN THREE LINES IN THE LEFT EYE AFTER REFRACTIVE SURGERY. SYMPTOMS ARE STILL CONTINUING. SURGEON IS PLANNING FOR RE-TREATMENT. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT CS, LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.