RayOne Aspheric RAO600C (REF RAO600C/+18.5)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
- 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 05029867692215), received between Dec 9, 2019 and Nov 24, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Ejection Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Ejection Problem1
- Optical Problem1
Patient problems
- Eye Injury1
- Intraocular Pressure Increased1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2025Optical Problem; Optical Problem
ON 11TH NOVEMBER 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPALNTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT IS EXPERIENCING POST-OPERATIVE NEGATIVE DYSPHOTOPSIA AND REQUIRED AN ADDITIONAL SURGERY TO EXPLANT AND EXCHANGE THE LENS.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 23629147 ↗MalfunctionJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 13TH MAY 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE PROFESSIONAL OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY, THE PATIENT PRESENTED WITH ELEVATED PRESSURE OF 39MMHG.
Patient problems: Intraocular Pressure Increased
MAUDE report 22123061 ↗MalfunctionDec 9, 2019Ejection Problem; Ejection Problem
ON (B)(6) 2019, 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 "AFTER THE IOL WAS HALFWAY OUT OF THE INJECTOR AND IN THE EYE, THE IOL QUICKLY CAME OUT THE REST OF THE WAY. THE LENS SHOT FORWARD VERY QUICKLY AND CAUSED THE ZONULES TO BE STRETCHED".
Patient problems: Eye Injury
MAUDE report 9437116 ↗
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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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