CLASS II ONGOING Device recall · Reported 13 Jul 2022 · FDA Enforcement Report
RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems recalled
Rayner Intraocular Lenses is recalling RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection, distributed nationwide in the US. The recall was initiated on 13 May 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1338-2022
- FDA event ID
- 90301
- Recalling firm
- Rayner Intraocular Lenses, Worthing, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 May 2022
- FDA classified
- 6 Jul 2022
- Reported
- 13 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Contact Lenses & Eye Devices
Timeline
| 13 May 2022 | Recall initiated by company | |
| 6 Jul 2022 | Classified by FDA | +54 days |
| 13 Jul 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The outer package is mislabeled and the package contains a different IOL strength.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.
Nationwide ArizonaCaliforniaFloridaGeorgiaIndianaMichiganMinnesotaMissouriNorth DakotaNew JerseyOklahomaTennesseeTexas
Questions about this recall
Why was it recalled?
The outer package is mislabeled and the package contains a different IOL strength.
Which lots 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.
Where was it sold?
US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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