MalfunctionNCF
ORA SYSTEM 2000
Received Jul 13, 2026
Report 2028159-2026-01044 · MDR key 25797279
Device
Generic name
Aberrometer, Ophthalmic
Manufacturer
Alcon Research, Llc - Irvine Technology CenterModel number
NACatalog number
8065753003
Lot number
NA
Product problems
- Defective Component
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
A NON HEALTHCARE PROFESSIONAL REPORTED LEVER HANDLE AND DOVETAIL SCREWS FELL OFF FROM THE SYSTEM AFTER REFRACTIVE SURGERY.THERE WAS NO PATIENT CONTACT.
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).