Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device

FDA device recall Z-1702-2008 · posted 2008-08-25 · Terminated

Recall details

Recalling firm

Advanced Medical Optics, Inc.

Reason for recall

AMO initiated this field correction event after becoming aware of a trend in complaints associated with AMO Vitrectomy Cutter used in conjunction with the AMO WHITESTAR SIGNATURE Phacoemulsification System. The physician may be unable to make a cut during cataract surgery.

Action taken

On April 2, 2008, AMO began distribution of an Urgent Safety Notice to all customers in the United States via overnight carrier (Federal Express). The U.S safety notice was used as a template for all global AMO communications regarding the Urgent Safety Notice , many of which required translation into local language prior to distribution. Included in this correspondence is a listing of the serial numbers of the affected products. The Notice informed customers of the problem and gave the customers modifications to the Vitrectomy Cutter Priming Instructions. In addition, the notice informed the customers that an AMO Field Service Engineer will be scheduling a site visit to modify a pressure setting on the AMO Whitestar Signature system. Contact the AMO Phaco Technical support at 1-877-AMO-4LIFE for assistance. AMO will provide updates to the FDA, including all information regarding the recall effectiveness as part of the recall progress reports.

Root cause

Device Design

Status

Terminated

Product code

HQC

Quantity affected

191 units

Distribution

Nationwide and to: AL, AR, CA, CO, FL, HI, IL, IN, MD, NC, ND, NJ, NY, OH, OR, PA, PR, SC, TX & WA and worldwide to: Azerbaijan, Belgium, Germany, Denmark, Egypt, Spain, France, Great Britain, Croatia

Date initiated

2008-04-02

Date posted

2008-08-25

Date terminated

2010-01-21

Location

Santa Ana, CA

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