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Recall Observatory FDA recall evidence

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

March 30, 2017

Class II

Product summary

Firm
Abbott Medical Optics Inc. (AMO)
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

    reason.labeling_packaging · v1.0.0

    Packaging error