RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens:
Summary
The FDA issued a Class II for RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS i by Rayner Intraocular Lenses Ltd. Reason: The outer package is mislabeled and the package contains a different IOL strength..
Details
Source
Device Recall
External ID
Z-1338-2022
Action Date
2022-07-13
Status
Ongoing
Category
device
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.
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.
Quantity Affected: 162 IOLs
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-13
Company
Worthing, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Rayner Intraocular Lenses Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Rayner Intraocular Lenses Ltd have FDA actions?
This is the only FDA action we have on record for Rayner Intraocular Lenses Ltd in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1338-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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