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.
- Company
- Abbott Medical Optics Inc (Amo)
- Recall Initiated
- March 30, 2017
- Posted
- May 16, 2017
- Terminated
- August 23, 2017
- Recall Number
- Z-2096-2017
- Quantity
- 360 units total
- Firm Location
- Santa Ana, CA
Reason for Recall
Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.
Distribution
Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
Lot / Code Info
Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)
Root Cause
Packaging process control
Action Taken
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.