RayOne Aspheric RAO600C (REF RAO600C/+22.5)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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05029867692291), received between Nov 14, 2019 and Jan 25, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Material Split, Cut or Torn1
Patient problems
- Corneal Edema1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ON (B)(6) 2023, RAYNER RECEIVED NOTIFICATION FROM ITS BRAZILIAN DISTRIBUTOR OF AN EVENT THAT OCCURRED DURING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE IOL GOT STUCK IN THE INJECTOR AND WAS IMPLANTED INTO THE EYE WITH A DAMAGED OPTIC NECESSITATING EXPLANTATION OF THE IOL.
Patient problems: Corneal Edema
MAUDE report 16240363 ↗MalfunctionNov 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ON 6TH NOVEMBER 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 PATIENT HAD A MYOPIC SURPRISE.
Patient problems: Visual Impairment
MAUDE report 9320211 ↗
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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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