CONSTELLATION SURGICAL PROCEDURE PACK
Received Jul 22, 2026 · Event occurred Jul 2, 2026
Report 1644019-2026-03986 · MDR key 25907804
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065000095
Lot number
181RFC
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Retinal Detachment
Narrative
Description of Event or Problem
A PHYSICIAN REPORTED THAT INFUSION CANNULA WAS PUT ON A PATIENT'S EYE, RETINAL DETACHMENT OCCURRED DURING THE SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THE OTHER SURGERY DETAILS WERE UNKNOWN. THE CURRENT PATIENT CONDITION WAS UNKNOWN.
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).H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.