Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS Recalled by Rayner Intraocular Lenses Ltd Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Rayner Intraocular Lenses Ltd directly.
Affected Products
RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.
Quantity: 162 IOLs
Why Was This Recalled?
The outer package is mislabeled and the package contains a different IOL strength.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Rayner Intraocular Lenses Ltd
Rayner Intraocular Lenses Ltd has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report