Home / Recalls / Rayner Intraocular Lenses Ltd / Z-1338-2022

Z-1338-2022 Class II Ongoing

Recalled by Rayner Intraocular Lenses Ltd — Worthing, N/A

Recall Details

Product Type: Devices
Report Date: July 13, 2022
Initiation Date: May 13, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 162 IOLs

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.

Distribution Pattern

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

Code Information

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.