- Device
- RayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615X
- Applicant
- Rayner Intraocular Lenses , Ltd.
- PMA number
- P060011
- Supplement
- S045
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2026-09-24
- Decision code
- APPR
- Date received
- 2026-02-12
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the RayOne Galaxy (RAO605G) and the RayOne Galaxy Toric (RAO615X). RayOne Galaxy (Model RAO605G) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia, in adult patients in whom a cataractous lens has been removed.The IOL mitigates the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity to a monofocal IOL.RayOne Galaxy is intended for implantation in patients with less than 1.00 diopter of pre-existing corneal astigmatism. The RayOne injection system is used to fold and assist in inserting the IOL into the eye.RayOne Galaxy Toric (Model RAO615X) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia, in adult patients in whom a cataractous lens has been removed.The IOL mitigates the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity to a monofocal IOL.In addition, RayOne Galaxy Toric is intended to provide reduction of residual refractive astigmatism in patients with corneal astigmatism greater than or equal to 1.03 diopter, up to 3.07 diopter. The RayOne injection system is used to fold and assist in inserting the IOL into the eye.