WaveLight EX500 Excimer Laser
Received Jul 31, 2026
Report 3003288808-2026-00318 · MDR key 50100062
Device
Generic name
Excimer Laser System
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065000122
Lot number
1414XH
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
28 YR · Male
- Dry Eye(s)
- Visual Impairment
- Visual Disturbances
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 Physician reported that patient had experienced persistent glare, halos, ghosting and rainbow patterns in the left eye after refractive surgery. The patient undergone treatment with medications, but the symptoms have remained constant despite ocular surface treatments.There are two related reports for this patient. This report addresses the patient MA, left eye and another manufacturer report will be filed for the fellow eye