Device product
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
Z-0798-2025
Product summary
- Event
- Event 95909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 120 units
- Official record key
device-enforcement:Z-0798-2025
Official wording
Reason: Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Code information: LOT NUMBER: 24G1880
Distribution pattern: IL, FL, SC. PA, AL Foreign: Netherlands
Derived failure modes
-
Potency or specification failure
out of specification