RayOne Aspheric RAO600C (REF RAO600C/+16.0)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 05029867692161), received between Sep 2, 2019 and May 28, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn1
- Optical Decentration1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON 15TH MAY 2025, RAYNER 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 LENS WAS TORN DURING INSERTION NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22094776 ↗MalfunctionJan 28, 2025Scratched Material; Scratched Material
ON 22ND JANUARY 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILTIY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT SCRATCHES WERE OBSERVED ON THE OPTIC NECESSITATING EXPLANTATION OF THE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21251197 ↗MalfunctionSep 2, 2019Optical Decentration; Optical Decentration
ON (B)(6) 2019, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY THE "LENS DECENTERED INFERIORLY".
Patient problems: No Information
MAUDE report 8953783 ↗
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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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