FDA Announces Class I Recall of Ophthalmic Surgical Device 02/06/2009 FDA가 안과 수술 후에 나타나는 염증이나 Toxic Anterior Segment Syndrome (TASS) 등의 문제들로 인해 Advanced Medical Optics Inc.(AMO)의 수술 기구들에 대해 리콜 조치를 취했다.
FDA는 리콜조취 된 기구를 가지고 있거나 회사측으로 부터 받은 샘플이 있다면 모두 AMO로 신속하게 돌려보낼 것을 촉구하였다.
The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.
OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.
On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). At that time, AMO informed customers of the number and nature of adverse event reports associated with OVD from that lot, and included a fax reply form for quick communication.
As of Dec. 3, 2008, AMO had retrieved 964 units and accounted for most of the 1,450 units that had been distributed in the United States.
AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.
TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens). TASS has been linked to solutions and devices used during eye surgery, such as OVDs, intraocular lenses and irrigation solutions.
The FDA urges anyone in possession of any units from the recalled lot, whether units were purchased from the company or provided as a sample by a sales representative, to remove them from inventory, and contact AMO
at 1-877-AMO-4Life to make arrangements for return. The lot number of the device is displayed on the side panel
of each unit.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to AMO by calling 1-877-AMO-4LIFE and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
*출처: FDA(Food and Drug Administration)
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01937.html
