FDA-Device2022-07-13Class II
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.
Rayner Intraocular Lenses Ltd
Hazard
The outer package is mislabeled and the package contains a different IOL strength.
Sold states
US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.
Affected count
162 IOLs
Manufactured in
10 Dominion Way, N/A, Worthing, N/A, United Kingdom
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1338-2022Don't want to check this manually?
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