CONSTELLATION SURGICAL PROCEDURE PACK
Received Jul 22, 2026 · Event occurred Jul 1, 2026
Report 1644019-2026-03935 · MDR key 25900440
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065000096
Lot number
ASKU
Product problems
- Use of Device Problem
- Suction Problem
Patient
37 YR · Female
- 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 HEALTHCARE PROFESSIONAL REPORTED THAT SIGNIFICANTLY REDUCED ASPIRATION WAS OBSERVED THROUGHOUT THE ENTIRE TUBING LENGTH, ALONG WITH SLOWED CUTTER OPERATION DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS CONTACT WITH PATIENT BUT NO IMPACT TO THE PATIENT.