CONSTELLATION SURGICAL PROCEDURE PACK
Received Jul 22, 2026 · Event occurred Jun 29, 2026
Report 1644019-2026-03949 · MDR key 25901934
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065752437
Lot number
17HJL3
Product problems
- Suction Problem
- Failure to Cut
- Ambient Noise Problem
Patient
NA · Unknown
- Insufficient Information
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 THE VITRECTOMY PROBE PRODUCED A HOARSE SOUND. ALTHOUGH ASPIRATION WAS PRESENT, BOTH THE FLOW RATE AND CUTTING EFFICIENCY WERE VERY LOW DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.