Device 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.
Z-1338-2022
Product summary
- Event
- Event 90301
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 162 IOLs
- Official record key
device-enforcement:Z-1338-2022
Official wording
Reason: The outer package is mislabeled and the package contains a different IOL strength.
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.
Derived failure modes
-
Labeling or packaging
mislabeled