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: +2
Check against the official notice below — it lists the full affected range.
Rayner Intraocular Lenses Ltd is recalling 162 RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems because the outer packages are mislabeled and contain intraocular lenses (IOLs) of a different strength than indicated on the label. The affected products were distributed nationwide to 13 states: Arizona, California, Florida, Georgia, Indiana, Michigan, Minnesota, Missouri, North Dakota, New Jersey, Oklahoma, Tennessee, and Texas. Two batches are involved: Batch #012183745 labeled as +19.0 D (with specific serial numbers and expiration date of 1/17/2024) and Batch #012183845 labeled as +21.0 D (all serial numbers, same expiration date).
The specific lot and batch numbers, along with serial numbers and UDI codes, are provided to help identify affected products. The source does not specify a remedy for consumers who may have received or been implanted with these mislabeled lenses.
Written by software from the official notice below. Not reviewed by a lawyer.
The outer package is mislabeled and the package contains a different IOL strength.
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. Quantity: 162 IOLs Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.