PMA P060011S039

Device: RayOne EMV Toric
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S039
Product code: HQL
Decision date: 2025-10-09
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: premarket approval application (PMA) supplement for the RayOne EMV Toric (Model RAO210T) consists of the EMV Toric IOL (210T) preloaded within the RayOne injection system (RAO). The EMV Toric IOL 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 by phacoemulsification and providing reduction of residual refractive astigmatism in adult patients with greater than or equal to 1.00 diopter (D) of corneal astigmatism. The RayOne injection system is used to fold and assist in inserting the IOL into the eye.

Current openFDA PMA Record#

Device: RayOne EMV Toric
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S039
Product code: HQL
Generic name: intraocular lens
Decision date: 2025-10-09
Decision code: APPR
Date received: 2025-03-17
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: premarket approval application (PMA) supplement for the RayOne EMV Toric (Model RAO210T) consists of the EMV Toric IOL (210T) preloaded within the RayOne injection system (RAO). The EMV Toric IOL 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 by phacoemulsification and providing reduction of residual refractive astigmatism in adult patients with greater than or equal to 1.00 diopter (D) of corneal astigmatism. The RayOne injection system is used to fold and assist in inserting the IOL into the eye.