Recall Z-1702-2008 ยท HQC Unit, Phacofragmentation
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.
| Date | Aug 25, 2008 (initiated Apr 2, 2008) |
| Status | Terminated |
| 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 t |
| 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, Portu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060366 | THE AMO OPHTHALMIC SURGICAL SYSTEM Advanced Medical Optics, Inc., Apr 7, 2006 |