Device Dossier
Slit lamp, ophthalmic
Device Dossier for Slit lamp, ophthalmic (Slit lamp, ophthalmic, Class IIb, sponsor MDSS AU). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Slit lamp, ophthalmic
Intended purpose
The RxSight Light Delivery Device (LDD) is used to improve uncorrected visual acuity by adjusting the Light Adjustable Lens RxLAL) power to correct rreesidual postoperative refractive error including -2.0 to +2.0 diopters of sphere and 0.50 to 3 diopters of cylinder and by changing lens curvature to introduce controlled amounts of spherical berration (+/- 1 micron) and center near add (up to 2 diopters). Following surgical implantation and a period of post-operative stabilization, patients return for examination and refractive adjustment in the office using a profiled beam of light from the Light Delivery Device (LDD).