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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615X
Generic NameLens, multifocal intraocular
ApplicantRayner Intraocular Lenses , Ltd.
1-2 Sackville Trading Estate,
Sackville Rd.
Hove, E. Sussex BN3 7AN
PMA NumberP060011
Supplement NumberS045
Date Received02/12/2026
Decision Date09/24/2026
Product Codes MFK MJP 
Advisory Committee Ophthalmic
Clinical TrialsNCT05985304
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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