RayOne Aspheric RAO600C (REF RAO600C/+19.0)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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05029867692222), received between Feb 13, 2020 and Jun 23, 2026 — classified as 7 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
- Scratched Material2
- Appropriate Device Problem Term/Code Not Available1
- Crack1
- Mechanical Problem1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2026Mechanical Problem
ON (B)(6) 2026, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES LENS EXPLANTED DUE TO "MECHANICAL COMPLICATIONS".
Patient problems: Insufficient Information
MAUDE report 25592681 ↗MalfunctionMar 3, 2026Crack
ON 18TH FEBRUARY 2026. 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 IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE THE OPTIC WAS CRACKED NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494671 ↗MalfunctionNov 3, 2025Positioning Problem; Scratched Material; Positioning Problem; Scratched Material
ON (B)(6) 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 ON IMPLANTATION INTO THE EYE SCRATCHES WERE OBSERVED ON THE IOL AND THE TRAILING HAPTIC WAS NOT IN THE EXPECTED POSITION. THE LENS WAS EXPLANTED AND EXCHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23450018 ↗MalfunctionNov 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON 16TH OCTOBER 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 WHEN THE SURGEON WAS IMPLANTING THE LENS THERE WAS SOME RESISTANCE AND WHEN DELIVERED INTO THE EYE ONE HAPTIC WAS BROKEN NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23448866 ↗MalfunctionJan 8, 2025Scratched Material; Scratched Material
ON 17TH DECEMBER 2024, 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 IMMEDIATELY FOLLOWING IMPLANTATION THE LENS WAS OBSERVED TO BE SCRATCHED NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21100983 ↗MalfunctionJan 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON (B)(6) 2023, 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 IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE THE LENS WAS OBSERVED TO HAVE TWO CRACKS ON THE OPTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18517127 ↗MalfunctionFeb 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2020, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS US AFFILIATE COMPANY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT ONE DAY POST-OPERATIVELY THE PATIENT PRESENTED WITH FIBRIN MEMBRANE OVER THE PUPIL.
Patient problems: No Code Available
MAUDE report 9705757 ↗
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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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