RayOne Preloaded Hydrophilic Acrylic IOL Injection recall: Labeling Error
RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as…
Why was RayOne Preloaded Hydrophilic Acrylic IOL Injection recalled?
The outer package is mislabeled and the package contains a different IOL strength.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as…
- Recalling firm
- Rayner Intraocular Lenses Ltd
- Quantity
- 162 IOLs
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.
- Recall date
- July 13, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)