Alcon Vitrectomy Products
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Constellation Vision System Viscous Fluid Control Pak With EnGauge RFID |
17DPRT |
8065-7509-57 |
Constellation Vision System Viscous Fluid Control Pak With EnGauge RFID |
17ERNK |
8065-7509-57 |
Chandelier W/RFID |
17DPN7 |
8065751577 |
Chandelier W/RFID |
17DPN8 |
8065751577 |
Endoillumination Probes |
17E0TX |
8065750972 |
Endoillumination Probes |
17C359 |
8065751441 |
Endoillumination Probes |
17C6U5 |
8065751441 |
Issue
Alcon is conducting this voluntary medical device field safety correction of impacted standalone vitrectomy consumables, as there is potential for some pouches within impacted lots to have an incomplete seal. While the incomplete seal is visibly noticeable within the pouch, due to the risk that the sterile barrier may be compromised, Alcon is conducting a recall.
Should a non-sterile product be used during surgery, post-operative infection may result requiring medical and/or surgical intervention.
To date, there have been no reported complaints for this issue from customers for the product in scope.
Recall start date: August 11, 2025
Additional information
Details
| Alcon Laboratories Inc. |
| 6201 South Freeway, Fort Worth, Texas, United States, 76134-2099 |
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