Rayner Intraocular Lenses Ltd: Medical Device Recall in 2022 - (Recall #: Z-1338-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 13, 2022

Date Posted: July 13, 2022

Recall Number: Z-1338-2022

Event ID: 90301

Reason for Recall:

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

Status: Ongoing

Product Quantity: 162 IOLs

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated