FDA recall Z-1338-2022

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 for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2022-05-13

Report date

2022-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Worthing, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1338-2022