VERION DIGITAL MARKER M
Received Jul 22, 2026 · Event occurred Jul 3, 2026
Report 3010300699-2026-00008 · MDR key 25903705
Device
Generic name
Marker, Ocular
Manufacturer
Wavelight Gmbh (agps)Model number
X-SPM-03Catalog number
8065998270
Lot number
158RVW
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT TORIC AXIAL ANGLE WAS DISPLAYED EXCEEDING AT TEN DEGREES AT THE TIME OF IMPLANTATION OF INTRAOCULAR LENS IN THE RIGHT EYE DURING REFRACTIVE SURGERY.THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.
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).