Advanced Medical Optics, Inc.: Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

Recall number

Z-1702-2008

Recalling firm

Advanced Medical Optics, Inc.

Product

Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

Status

Terminated

Initiated

2008-04-02

Posted

2008-08-25

Terminated

2010-01-21

Reason

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.

Root cause

Device Design

Action

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.

Quantity

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, Hungary, Israel, Italy, Jordan, Kuwait, Lebanon, Liechtenstein, Netherlands, Norway, Poland, Portugal, Saudia Arabia, Sweden, Turkey, South Africa, Australia, India, New Zealand and Singapore

Lot, serial or model codes

Product Number: NGP680300, Lot Numbers: 200750010, 200750016, 200750017, 200750018, 200750019, 200750020, 200750021, 200750024, 200750025, 200750027, 200750028, 200750031, 200750037, 200750042, 200750045, 200750046, 200750051, 200750052, 200750055, 200750056, 200750058, 200750065, 200750067, 200750068, 200750074, 200750079, 200750080, 200750090, 200750094, 200750100, 200750102, 200750110, 200750113, 200750136, 200750137, 200750138, 200750139, 200750140, 200750154, 200750158, 200750159, 200750160, 200750161, 200750162, 200750164, 200750166, 200750167, 200750194, 200750196, 200750199, 200750205, 200750206, 200750209, 200750215, 200750216, 200750222, 200750224, 200750226, 200750229, 200750235, 200850064, 200850066, 200850069, 200850089, 200850092, 200850108, 200850109, 200850111, 200850112, 200750038,  200750040, 200750043, 200750049, 200750064, 200750066, 200750070, 200750085, 200750087, 200750088, 200750089, 200750091, 200750096, 200750097, 200750105, 200750106, 200750107, 200750112, 200750114, 200750115, 200750117, 200750118, 200750119, 200750122, 200750123, 200750126, 200750127, 200750142, 200750143, 200750144, 200750145, 200750146, 200750148, 200750150, 200750151, 200750152, 200750153, 200750155, 200750163, 200750168, 200750169, 200750170, 200750171, 200750173, 200750175, 200750176, 200750177, 200750178, 200750179, 200750184, 200750185, 200750187, 200750189, 200750190, 200750191, 200750192, 200750195, 200750232, 200750238, 200750239, 200750240, 200750242, 200750243, 200750244, 200850001, 200850002, 200850003, 200850015, 200850017, 200850018, 200850020, 200850021, 200850022, 200850026, 200850027, 200850028, 200850037,  200850040,  200850041, 200850043, 200850044, 200850045, 200850046, 200850047, 200850049, 200850050, 200850051, 200850052, 200850053, 200850055, 200850056, 200850057, 200850058, 200850059, 200850073, 200850074, 200850075, 200850076, 200850078, 200850079, 200850080, 200850081, 200850082, 200850083, 200850084, 200850085, 200850086, 200850098, 200850099, 200850100, 200850102, 200850103, 200850106, 200850114, 200850122,  200750047, 200750073, 200750095, 200750099, 200750156, 200850007, 200850060

510(k) numbers

["K060366"]

PMA numbers

not on file

Product code

HQC

Firm FEI

3003843509

Firm city

Santa Ana

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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