This article is more than 5 years old. Information may no longer be current.
FDA panel recommends wavefront-guided system for approval with conditions
GAITHERSBURG, Md. — A system for performing wavefront-guided LASIK received an “approvable with conditions” recommendation from a regulatory panel here last week.
Alcon Surgical’s CustomCornea system is the first wavefront-guided LASIK system to receive recommendation for approval in the United States, according to the manufacturer.
The Food and Drug Administration’s Ophthalmic Devices Panel unanimously voted the system approvable for the correction of myopia up to -7 D at its meeting here last Thursday.
The CustomCornea system uses the LADARVision 4000 excimer laser and the LADARWave wavefront measuring device. Clinical trials using the system are continuing for the treatment of myopic astigmatism, hyperopia with and without astigmatism and other ocular irregularities.
Concerns about the device’s labeling led to the conditional recommendation. Specifically, the panel was concerned about efficacy claims and patient education in its labeling. Wording in the system's labeling did not adequately explain the relationship between higher-order aberrations and wavefront-guided ablations, the panel said. The customized ablation system does not reduce preoperative higher-order aberrations, the panel stated, but rather induces fewer aberrations postoperatively than conventional LASIK systems — specifically the LADARVision.