Date Initiated by Firm |
March 30, 2017 |
Date Posted |
May 16, 2017 |
Recall Status1 |
Terminated 3 on August 23, 2017 |
Recall Number |
Z-2096-2017 |
Recall Event ID |
77024 |
510(K)Number |
K081681
|
Product Classification |
Vitrectomy, instrument cutter - Product Code MLZ
|
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. |
Code Information |
Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units) |
Recalling Firm/ Manufacturer |
Abbott Medical Optics Inc. (AMO) 1700 E Saint Andrew Pl Santa Ana CA 92705-4933
|
For Additional Information Contact |
714-247-8200
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
360 units total |
Distribution |
Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = MLZ and Original Applicant = ADVANCED MEDICAL OPTICS, INC.
|