ORA SYSTEM WITH VERIFEYE MESSAGING
Received Jul 2, 2026 · Event occurred May 7, 2026
Report 2028159-2026-00952 · MDR key 25686740
Device
Generic name
Aberrometer, Ophthalmic
Manufacturer
Alcon Research, Llc - Irvine Technology CenterModel number
NACatalog number
8065998330
Lot number
NA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
57 YR · Female
- 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 PATIENT WAS UNHAPPY WITH THE VISION, AND THE INTRAOCULAR LENS WAS EXPLANTED DUE TO THE SYSTEM SUGGESTING INCORRECT READINGS, WHICH RESULTED IN THE SELECTION OF AN INCORRECT LENS POWER IN THE LEFT EYE DURING REFRACTIVE SURGERY. ADDITIONAL RELATED INFORMATION WAS REQUESTED HAS BEEN REPORTED.