MalfunctionGAZ
VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT)
Received May 14, 2026 · Event occurred Apr 15, 2026
Report 1644019-2026-02593 · MDR key 25170318
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Product code (GAZ)
Model (NA)
Device
Generic name
Tubing, Noninvasive
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065750957
Lot number
175WY7
Product problems
- Defective Device
Patient
NA · Unknown
- 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 NURSE REPORTED THAT THE TUBING WAS BLOCKED MAKING IT IMPOSSIBLE TO COMPLETE THE SILICONE OIL INJECTION DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.