MalfunctionLRO
CONSTELLATION SURGICAL PROCEDURE PACK
Received Jul 22, 2026 · Event occurred Jun 26, 2026
Report 1644019-2026-03966 · MDR key 25905989
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065752437
Lot number
17FXC3
Product problems
- Failure to Cut
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 VITRECTOMY PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.