Device product
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
Z-2096-2017
Product summary
- Event
- Event 77024
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360 units total
- Official record key
device-enforcement:Z-2096-2017
Official wording
Reason: Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.
Code information: Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)
Distribution pattern: Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
Derived failure modes
-
Labeling or packaging
Packaging error