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U.S. Department of Health and Human Services

Class 2 Device Recall AMO Vitrectomy Cutter

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  Class 2 Device Recall AMO Vitrectomy Cutter see related information
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.
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