RayOne EMV RAO200E (REF RAO200E/+21.5)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
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05029867006739), received between May 30, 2023 and Apr 9, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Ejection Problem1
- Optical Problem1
Patient problems
- Visual Impairment3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026Optical Problem
ON 27TH MARCH 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT WAS DISSATISFIED WITH THEIR POST-OPERATIVE VISION AND ELECTED TO UNDERGO AN ADDITIONAL SURGERY TO EXPLANT AND EXCHANGE THE LENS.
Patient problems: Visual Impairment
MAUDE report 24829733 ↗MalfunctionJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 7TH JUNE 2024, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS NEEDED TO BE EXPLANTED IN A SECONDARY SURGERY DUE TO A REFRACTIVE ISSUE.
Patient problems: Visual Impairment
MAUDE report 19603989 ↗MalfunctionFeb 22, 2024Break; Ejection Problem; Break; Ejection Problem
ON 6TH FEBRUARY 2024, RAYNER RECEIVED NOTIFICATION FROM ITS DISTIRBUTOR IN SOUTH AFRICA OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PLUNGER GOT STUCK IN INJECTOR AND THE IOL BROKE. AS A RESULT OF THE EVENT THE PATIENT WAS LEFT APHAKIC, DUE TO UNAVAILABILITY OF A BACK-UP LENS, REQUIRING A SECONDARY IMPLANTATION SURGERY.
Patient problems: Visual Impairment
MAUDE report 18756496 ↗MalfunctionMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2023, RAYNER RECEIVED NOTIFICATION FROM ITS FRENCH AFFILIATE COMPANY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS LEFT THE INJECTOR TOO FAST BREAKING THE CAPSULAR BAG.
Patient problems: Insufficient Information
MAUDE report 17018882 ↗
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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
- 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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