Home / Recalls / Medical Devices
Rayner Intraocular Lenses Ltd recalls RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens:
Recalled July 13, 2022 · FDA recall Z-1338-2022 · Rayner Intraocular Lenses
Hazard
The outer package is mislabeled and the package contains a different IOL strength. · FDA Class II
Units
162 IOLs
Sold at
US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.
Description
The outer package is mislabeled and the package contains a different IOL strength.
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.
Manufacturer(s)
Rayner Intraocular Lenses Ltd
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →