CONSTELLATION SURGICAL PROCEDURE PAK
Received Jul 22, 2026 · Event occurred Jun 1, 2026
Report 1644019-2026-03951 · MDR key 25902290
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
ASKU
Lot number
ASKU
Product problems
- Failure to Cut
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE DID NOT CUT DURING CALIBRATION. THE PROCEDURE TYPE AND SURGERY COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.
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).H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.