CONSTELLATION Surgical Procedure Pack
Received Jul 29, 2026 · Event occurred Jun 24, 2026
Report 1644019-2026-04058 · MDR key 50065613
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065752450
Lot number
18042R
Product problems
- Suction Problem
- Infusion or Flow Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A health care professional reported that cassette failed to perform irrigation & aspiration functionsduring cataract surgery (without intraocular lens implant). The surgery was completed on same day by replacing the product with another. There was no patient impact.
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).