Device product
Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
Z-1111-2019
Product summary
- Firm
- Beaver Visitec
- Event
- Event 82382
- Status
- Terminated
- Classification
- Class II
- Quantity
- 196 boxes (10units/box)
- Official record key
device-enforcement:Z-1111-2019
Official wording
Reason: Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device
Code information: Lot Number: 6008554
Distribution pattern: Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS
Derived failure modes
-
Labeling or packaging
Mislabeled