Two algorithms corrected on Alcon excimer laser system

Alcon Laboratories said it has completed a recall concerning two algorithms for myopia with and without astigmatism for customized LASIK procedures (CustomCornea) with its excimer laser system (LADAR6000). The recall, which affected 102 excimer laser units, was limited to the algorithms and not the device. After first notifying device owners of the problem in February, the company informed surgeons May 11 that it would disable the system's ability to perform the two procedures. Those deactivations are completed, the FDA said.

Key Points

Fort Worth, TX-Alcon Laboratories said it has completed a recall concerning two algorithms for myopia with and without astigmatism for customized LASIK procedures (CustomCornea) with its excimer laser system (LADAR6000). The recall, which affected 102 excimer laser units, was limited to the algorithms and not the device, the company said.

According to the FDA, the algorithms for myopia with astigmatism (M3) and myopia without astigmatism (A7) caused corneal abnormalities or "central islands" and decreased visual acuity in patients.

"These 'central islands' may not be correctable with lasers," the FDA reported. "Additionally, the decrease in visual acuity may not be correctable with glasses or contact lenses."

According to the FDA, 18 units were still in Alcon's possession, and a freight handler was holding two others.

The units were manufactured by Alcon Refractive Horizon Inc., an Orlando-based division of Alcon, and distributed from Aug. 17, 2005 to Feb. 21, 2007. The excimer laser system is used for LASIK and wavefront-guided LASIK treatment for the reduction or elimination of mild-to-moderate myopia and hyperopia with or without astigmatism and for mixed astigmatism in patients aged 21 years or more with documented stability of refraction for the prior 12 months.

The recall was described as class I, the most serious type, because of the potential for serious injury, according to the FDA.

The irregularities affected 89 eyes of 50 patients, Golden said.

"On a limited number of [the excimer laser] systems, it is believed that a combination of laser firing speed and shot-spiral sequence caused rough ablations during certain custom myopia procedures," Golden explained.

When the excimer laser system was approved by the FDA in May 2006, Alcon said the unit featured a 50% faster ablation rate than previous platforms of the company's excimer laser system and that it "significantly decrease[d] surgical time, especially in higher refractive correction ranges, and result[ed] in less exposure of the corneal flap."

At the same time, the FDA had approved "the industry's broadest wavefront-guided hyperopic indication for Alcon's customized LASIK procedure on both the LADAR6000 laser and the LADARVision 4000 System." With this approval, ophthalmologists were able to treat hyperopia and hyperopic astigmatism (0.75 to 5 D sphere with up to –3 D cylinder) in addition to the existing range for myopia and myopic astigmatism.

After first notifying device owners of the problem in February, the company informed surgeons May 11 that it would disable the system's ability to perform the two procedures. Those deactivations are completed, the FDA said.

Alcon replaced some LADAR6000 lasers with previous-generation lasers (LADAR-Vision 4000) at the request of some surgeons, Golden said.

About 40% of procedures performed on the device are customized LASIK procedures, she said. Of those, 80% were performed on myopic patients using those algorithms.

Golden said it is too early, however, to tell the financial impact of this recall.

"The refractive product line represent[ed] approximately 1% of our total global sales in 2006," she said. "Therefore, the impact to the company as a whole is expected to be minimal."