FDA Product Code HQC: Unit, Phacofragmentation

Cataract surgery is the most commonly performed ophthalmic procedure worldwide. FDA product code HQC covers phacofragmentation units used to emulsify and aspirate the cataractous lens.

These systems use ultrasonic vibration at the tip of a needle to fragment the lens nucleus into small pieces that are simultaneously aspirated, allowing removal of the opaque lens through a small incision before intraocular lens implantation.

HQC devices are Class II medical devices, regulated under 21 CFR 886.4670 and reviewed by the FDA Ophthalmic panel.

Leading manufacturers include Storz Instrument Co., CooperVision, Inc. and Chiron Vision Corp..