Rayner Intraocular Lenses Ltd recalls RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems c
Recalled Product
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.
Hazard / Issue
The outer package is mislabeled and the package contains a different IOL strength.
Issued by
FDA
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