CONSTELLATION Surgical Procedure Pack
Received Jul 31, 2026 · Event occurred Jul 1, 2026
Report 1644019-2026-04095 · MDR key 50094798
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065753106
Lot number
17MAM5
Product problems
- Failure to Cut
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A healthcare professional reported that the vitrectomy probe had degraded during pars plana vitrectomy surgery, resulting in a loss of cutting function. The surgery was completed after replacing the probe with another one. There was no impact to the patient.
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)