FDA Device Recall Z-2096-2017: Abbott Medical Optics Inc. (AMO)

Recall Parameters & Description

Normalized public record details for FDA recall code Z-2096-2017.

Recall Res Number

Z-2096-2017

Recalling Firm / Manufacturer

Abbott Medical Optics Inc. (AMO)

FEI Number

3003843509

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-03-30

Date Posted

2017-05-16

Date Terminated

2017-08-23

Product Code

MLZ

Event Number

77024

Product Quantity

360 units total

Product Description 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.

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.

Action Details 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.

Distribution Pattern Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.

Code Information / Serial Numbers Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)

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Medical Device Recall: Z-2096-2017

Recall Parameters & Description

Related Establishments / Registrations

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