CONSTELLATION SURGICAL PROCEDURE PACK
Received Jul 22, 2026 · Event occurred Jun 30, 2026
Report 1644019-2026-03946 · MDR key 25901827
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065000095
Lot number
181RFC
Product problems
- Suction Problem
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 PHYSICIAN REPORTED THAT ACTUATION OF A CUTTER WAS UNSTABLE AND IT COULD NOT ASPIRATE DURING THE CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT UNKNOWN HOW IT WAS COMPLETED. THERE WAS NO PATIENT CONTACT.