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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Advanced Medical Optics, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Advanced Medical Optics, Inc. is recalling Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NG due to AMO initiated this field correction event after becoming aware of a trend in complaints associated with AMO Vitrectomy Cutter used in conjunction with. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026