RayOne Aspheric RAO600C (REF RAO600C/+22.0)Recalls & reported problems
Rayner Intraocular Lenses Limited · Class 3 · Implant
All models of RayOne Aspheric (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05029867692284), received between Aug 24, 2022 and Apr 28, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).
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
- Material Split, Cut or Torn2
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Material Split, Cut or Torn
ON 16TH APRIL 2026, RAYNER RECEIVED NOTIFICATION FROM ITS US REPRESENTATIVES OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE HAPTIC WAS TORN ON IMPLANTATION INTO THE EYE NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016210 ↗MalfunctionFeb 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ON 15TH FEBRUARY 2023, RAYNER RECEIVED NOTIFICATION FROM A UK HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE THE IOL OPTIC WAS OBSERVED TO BE BROKEN NECESSITATING LENS EXPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16407542 ↗MalfunctionAug 24, 2022Material Integrity Problem; Material Integrity Problem
ON (B)(6) 2022, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE SURGEON OBSERVED AN IMPERFECTION ON THE OPTIC IMMEDIATELY POST IMPLANTATION AND EXPLANTED THE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15281635 ↗
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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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