WAVELIGHT EX500 EXCIMER LASER
Received Jul 15, 2026 · Event occurred Jun 8, 2026
Report 3003288808-2026-00304 · MDR key 25822716
Device
Generic name
Ophthalmic Excimer Laser System
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065990713
Lot number
NA
Product problems
- Incorrect Interpretation of Signal
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
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 NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE UNSPECIFIED METAL INSTRUMENT USED TO PROTECT THE HINGE OF THE FLAP, AND THIS APPEARED TO HAVE AFFECTED THE EYE TRACKER IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY.