Recall Z-2096-2017 ยท MLZ Vitrectomy, Instrument Cutter
Abbott Medical Optics Inc. (AMO)
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.
| Date | May 16, 2017 (initiated Mar 30, 2017) |
| Status | Terminated |
| Reason | Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package. |
| Root cause | Packaging process control |
| Action | An Urgent Field Safety notice was sent on 3/30/17 to inform customers that AMO has voluntarily initiated this Action because a possibility exists that, due to a packaging error, 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package. Use of a Vitrectomy Cutter that is a different size than expected could lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and scleral sutures. |
| Quantity | 360 units total |
| Distribution | Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081681 | VITRECTOMY CUTTER AND ACCESSORIES Advanced Medical Optics, Inc., Oct 8, 2008 |