RayOne EMV RAO200E (REF RAO200E/+21.0)Recalls & reported problems
Rayner Intraocular Lenses Limited · Class 3 · Implant
All models of RayOne EMV (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05029867006722), received between Oct 8, 2024 and Oct 8, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- May 13, 2022Open, Classified
The outer package is mislabeled and the package contains a different IOL strength.
Z-1338-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Eject1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 25TH SEPTEMBER 2024, RAYNER RECEIVED NOTIFICATION FROM A HEALTHHCARE FACILITY IN FRANCE OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS WAS TORN DURING IMPLANTATION NECESSITATING EXPLANTATION OF THE IOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20395175 ↗MalfunctionOct 8, 2024Failure to Eject; Failure to Eject
ON 25TH SEPTEMBER 2024, RAYNER RECEIVED NOTIFICATION FROM A HEALTHCARE FACILITY IN FRANCE OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS GOT STUCK IN THE INJECTOR, RESULTING IN PROLONGED SURGERY. NOTE: THIS IS THE BACK-UP LENS ASSOCIATED WITH RAYNER CASE (B)(4) - FDA MDR 3012304651-2024-00269.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20395173 ↗
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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