CLASS II Device recall · Reported 30 Nov 2022 · FDA Enforcement Report
regard Cataract, EY00450K recalled by ROi CPS
ROi CPS is recalling regard Cataract, EY00450K, distributed in Florida, Louisiana, Missouri, North Carolina. The recall was initiated on 20 Oct 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-0315-2023
- FDA event ID
- 91069
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Oct 2022
- FDA classified
- 23 Nov 2022
- Reported
- 30 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Oct 2022 | Recall initiated by company | |
| 23 Nov 2022 | Classified by FDA | +34 days |
| 30 Nov 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
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product as listed by the FDA
regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
Where it was distributed
LA, MO, NC, FL
Questions about this recall
Is regard Cataract, EY00450K recalled?
Yes. ROi CPS recalled regard Cataract, EY00450K on 20 Oct 2022. The recall is Class II and its status is Terminated. Recall number Z-0315-2023.
Why was it recalled?
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Which lots are affected?
UDI/DI 10194717104643, Lot Numbers: 91479, exp 2/10/2024
Where was it sold?
LA, MO, NC, FL
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 21 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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