AMO recalls lens care solution

January 1, 2007

Advanced Medical Optics (AMO) has voluntarily recalled certain lots of its 12 ounce COMPLETE MoisturePLUS multipurpose contact lens care solution and Active Packs, sold in the US.

Advanced Medical Optics (AMO) has voluntarily recalled certain lots of its 12 ounce COMPLETE MoisturePLUS multipurpose contact lens care solution and Active Packs, sold in the US.

The recall was initiated after three lots sold in Japan were found to have bacterial contamination which compromised sterility. The non-sterility of contact lens solution could have serious health consequences, including eye infection and microbial keratitis. Contact lens wearers who experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling are being advised to remove the lenses and consult their eye care provider immediately.

The recall does not include four and 16 ounce bottles or professional samples and packs provided to eye care practitioners. AMO has yet to receive any adverse reports associated with the product in the US.

The cause of a hyperopic shift, seen on rare occasions after implantation of the STAAR one-piece collamer lens, appears to be capsular fibrosis, according to a report in the December 2006 issue of the Journal of Cataract & Refractive Surgery.

Since the lens was introduced in 2000, more than 160,000 have been implanted. However, there have been 40 reported cases of gradual hyperopic shift averaging 1.81 D. Donald Sanders, MD, PhD, led a team to conduct a retrospective data analysis of the cases. Among the parameters being explored was refractive change, presence of capsular fibrosis, IOL displacement and outcomes of secondary treatments.

The researchers found that, in five cases (14%), the hyperopic shift was greater than 3.0 D. In 38 of the 40 cases, some combinations of the following were reported: posterior displacement of the IOL, capsule fibrosis, and/or relief of the condition by performance of a radial or circumferential anterior neodymium:YAG capsulotomy to relieve tension. The use of a small (less than 5.5 mm) capsulorhexis was also associated with cases showing hyperopic shift.

The researchers concluded that the most likely cause of the hyperopic shift was the development of anterior capsule fibrosis. This was sometimes exacerbated by a small capsulorhexis which could cause the IOL to move posteriorly, resulting in a hyperopic change in refraction. Previous investigations by STAAR ruled out a change in the actual refractive power of the lens.

STAAR to provide additional TICL data

The FDA has requested additional information and analyses of clinical data from STAAR regarding its Visian toric implantable collamer lens (TICL).

STAAR submitted the application for Visian TICL in April of last year as a supplement to the pre-market approval application for its Myopic Visian ICL, which the FDA approved in December 2005.

The information requested pertains to safety and efficacy data, in addition to data regarding a transitory rise in the rate of excessive ICL vaulting. STAAR believes that this rise resulted from the learning curve of surgeons in measuring and assessing key variables. In the last few months, this rate has decreased to below the 0.6% rate reported during the US clinical trials.

Tecnis launch delayed

The FDA has recommended that AMO enrolls additional subjects in its US clinical study of the Tecnis multifocal intraocular lens (IOL).

Despite this news, AMO still intends to file a premarket approval application for the lens, in accordance with its original plan to launch the lens in the US during the first half of 2008. However, because of the FDA recommendations, the company now believes the product will be launched 12-18 months later than expected.

Alcon recalls Systane

Alcon Laboratories has announced a voluntary recall of Systane Free LIQUID GEL lubricant eye drops.

The recall has come in response to 11 consumer reports citing the presence of a foreign material in the product. After testing the returned bottles, Alcon has identified the material as mold but because of the characteristics of the mold, it believes the development of infection is unlikely.

The product is only available in the United States and, since its introduction in January 2006, more than five million bottles have been distributed. The recall does not apply to any other formulations of Systane lubricant eye drops.

The FDA has been notified of the voluntary action.