RayOne Aspheric RAO600C (REF RAO600C/+24.0)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 05029867692321), received between Nov 12, 2019 and Sep 8, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (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
- Optical Problem2
- Insufficient Device Problem Information1
Patient problems
- Visual Impairment2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2025Optical Problem; Optical Problem
ON 28TH AUGUST 2025, 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 THAT POST-OPERATIVELY THE PATIENT PRESENTED WITH A REFRACTIVE SURPRISE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22990124 ↗MalfunctionJul 14, 2025Optical Problem; Optical Problem
ON 2ND JULY 2025, 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 THAT POST-OPERATIVELY THE PATIENT EXPERIENCED VISUAL IMPAIRMENT NECESSITATING DEVICE EXPLANTATION AND EXCHANGE.
Patient problems: Visual Impairment
MAUDE report 22494167 ↗MalfunctionNov 12, 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 9310265 ↗
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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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