Device product
Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
Z-0782-2023
Product summary
- Event
- Event 91235
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 599 units (US): 410 units; 189 kits
- Official record key
device-enforcement:Z-0782-2023
Official wording
Reason: Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection
Code information: UDI: 00886158100010 Lot Number: 3391035 Additionally Packaged as a component of the READYPAK KIT Cat: 584896 Lots: 6054175, 6053035
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Sterility assurance
sterile barrier has been compromised