Rayner Intraocular Lenses product recalled over labeling errors

Recall date

May 13, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Rayner Intraocular Lenses Ltd recalls RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens:…

Recall number

Z-1338-2022

FDA classification

Class II

Brand / firm

Rayner Intraocular Lenses Ltd

Sold / distributed

US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.

Why it was recalled

The outer package is mislabeled and the package contains a different IOL strength.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.