AMO capsular tension ring gets U.S. marketing approval

StabilEyes, a capsular tension ring designed for use in complicated cataract surgery, was granted U.S. marketing approval yesterday, according to a joint press release from the device’s marketer and manufacturer.

Advanced Medical Optics will be the designated marketer of StabilEyes in the United States, Canada and Mexico, while the ring’s manufacturer, Ophtec, retains marketing rights elsewhere. Ophtec has marketed the device for more than 10 years in Europe as Oculaid, the press release noted. Ophtec began clinical trials on the StabilEyes device in the U.S. in 2001.

The AMO/Ophtec device joins the capsular tension ring from Morcher as the second such device to receive approval in the United States. The Morcher ring was approved in October of last year.

“Capsular tension rings offer the surgeon a new level of safety for complicated cataract cases,” said Russ Trenary, chief marketing officer for AMO. “By stabilizing the capsular bag with StabilEyes, surgeons will have the ability to easily perform successful posterior chamber IOL implantation when the integrity of the capsular bag is, or may become, compromised.”

StabilEyes is a uniplanar, 270· ring made entirely of ultraviolet-light-absorbing PMMA with one manipulation eyelet at each end of the ring, according to the press release from AMO and Ophtec. Its function is to stabilize the capsular bag, especially in patients with weak or broken zonules, during cataract surgery. About 1% to 3% of patients undergoing cataract surgery experience zonular damage during the course of surgery, the press release noted.