medical Class II Updated 2022-07-13

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

Distribution: Nationwide (United States)
Lot/Code Info: Outer carton +19.0 D - Batch #012183745, exp. 1/17/2024, Serial numbers 01-06, 10, 21, 24-45, 48-53, 58-60, 61-65, and 68-81, UDI (01)05029867006685. Outer carton +21.0 D - Batch #012183845, exp. 1/17/2024, all serial numbers, UDI (01)05029867006722.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →