Reported Jul 13, 2022 · Ongoing
RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens:…
Rayner Intraocular Lenses Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Rayner Intraocular Lenses Ltd · 10 Dominion Way · Worthing, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
- 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.
- Amount recalled
- 162 IOLs
Where it was sold
Why it was recalled
The outer package is mislabeled and the package contains a different IOL strength.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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