| 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. |
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| Device | RayOne EMV Toric |
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| Generic Name | intraocular lens |
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| Applicant | Rayner Intraocular Lenses , Ltd.
1-2 Sackville Trading Estate,
Sackville Rd.
Hove, E. Sussex BN3 7AN |
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| PMA Number | P060011 |
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| Supplement Number | S039 |
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| Date Received | 03/17/2025 |
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| Decision Date | 10/09/2025 |
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| Product Codes |
HQL MJP |
| Advisory Committee |
Ophthalmic |
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| Clinical Trials | NCT05985304
|
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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