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Ophthalmic Professional

Article

FDA Approves Rayner's RayOne EMV Toric IOL 

The approval follows the successful completion of a pivotal Investigational Device Exemption study. 

Ophthalmic Professional October 13, 2025

Clinical Report: FDA Approves Rayner's RayOne EMV Toric IOL

Overview

The FDA has approved the RayOne EMV Toric intraocular lens (IOL) following a pivotal IDE study demonstrating its effectiveness in correcting astigmatism. The lens showed excellent rotational stability and visual performance, making it a significant addition to surgical options for patients with corneal astigmatism.

Background

The approval of the RayOne EMV Toric IOL is crucial as it addresses the need for effective astigmatism correction in cataract surgery. With increasing emphasis on achieving optimal visual outcomes, this lens provides surgeons with a reliable option for patients with ≥1.00 D of corneal astigmatism. The lens's design and performance metrics align with contemporary clinical standards and guidelines.

Data Highlights

ParameterRayOne EMV ToricControl Monofocal IOL
Absolute Mean Rotation (Day 1)0.9°N/A
Absolute Mean Lens Alignment (Month 6)3.5°N/A
Eyes Rotating ≤5°99%N/A
BCVA ≥20/40 at Month 6100%N/A
Cystoid Macular Edema1.7%N/A
IOL Repositioning for Misalignment0.9%N/A

Key Findings

  • The RayOne EMV Toric IOL demonstrated an absolute mean rotation of 0.9° at day 1 post-operation.
  • At 6 months, the absolute mean lens alignment was 3.5°, with 99% of eyes showing ≤5° rotation.
  • 93.9% of eyes achieved <10° from the intended axis at 4-6 months.
  • 100% of patients achieved best-corrected visual acuity (BCVA) of ≥20/40 by month 6.
  • Safety endpoints were met with low rates of cystoid macular edema (1.7%) and IOL repositioning (0.9%).

Clinical Implications

The RayOne EMV Toric IOL provides a robust option for surgeons aiming to correct astigmatism during cataract surgery. Its proven stability and visual outcomes may enhance patient satisfaction and reduce the need for additional corrective procedures.

Conclusion

The FDA approval of the RayOne EMV Toric IOL marks a significant advancement in the management of astigmatism in cataract surgery, offering surgeons a reliable tool to improve patient outcomes.

References

  1. Rayner, FDA, 2025 -- FDA Approves Rayner's RayOne EMV Toric IOL
  2. Ophthalmology Management, 2020 -- PRODUCT SPOTLIGHT
  3. Corneal Physician, 2022 -- Selecting an IOL
  4. Ophthalmology Management, 2026 -- FDA Clears Rayner's Sophi Phaco System
  5. Ophthalmology Management — Quick Hits: Ophthalmology News From March 2024
  6. Correspondence Generator (CorGen)
  7. ANSI Z80.30-2018 (R2023) - Ophthalmics - Toric Intraocular Lenses
  8. Real-world outcomes of cataract surgeries using a new type of enhanced monofocal toric intraocular lens | Scientific Reports