CONSTELLATION Surgical Procedure Pack
Received Jul 28, 2026 · Event occurred Jul 6, 2026
Report 1644019-2026-04021 · MDR key 50049689
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065752437
Lot number
180437
Product problems
- Suction Problem
- Failure to Cut
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A physician reported that the vitrectomy probe was unable to cut and aspirate even when the cutting speed was reduced below 3000 cuts per minute, while all other accessories in the package functioned normally during vitrectomy surgery. The surgery was completed on the same day after being replaced with new product. There was no impact on 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).