Recall Z-1338-2022— Rayner Intraocular Lenses Ltd

Name: FDA recall Z-1338-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-13

Class II · Ongoing

Class II FDA medical device recall by Rayner Intraocular Lenses Ltd, initiated 2022-05-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The outer package is mislabeled and the package contains a different IOL strength..

Recalling firm: Rayner Intraocular Lenses Ltd
Classification: Class II
Status: Ongoing
Initiated: 2022-05-13
Firm location: Worthing, N/A, United Kingdom

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.