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.
Reported: July 13, 2022 Initiated: May 13, 2022 #Z-1338-2022
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.
Reason for Recall
The outer package is mislabeled and the package contains a different IOL strength.
Details
- Recalling Firm
- Rayner Intraocular Lenses Ltd
- Units Affected
- 162 IOLs
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.
- Location
- Worthing, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Rayner Intraocular Lenses Ltd. Units affected: 162 IOLs.
Why was this product recalled? ▼
The outer package is mislabeled and the package contains a different IOL strength.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2022. Severity: Moderate. Recall number: Z-1338-2022.
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