RayOne Aspheric RAO600C (REF RAO600C/+17.0)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
- 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 05029867692185), received between May 28, 2025 and May 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 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 POSTERIOR CAPSULE OPACIFICATION (PCO) NECESSITATING AN ADDITIONAL SURGERY TO YAG THE CAPSULE.
Patient problems: Visual Impairment
MAUDE report 22105083 ↗MalfunctionMay 28, 2025Scratched Material; Scratched Material
ON 13TH MAY 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE PROFESSIONAL OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE GALAXY RAO605G. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION, A LARGE SCRATCH WAS OBSERVED IN THE VISUAL AXIS NECESSITATING LENS EXPLANTATION AND EXCHANGE. NOTE: RAYONE GALAXY STUDY SUBJECT: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22094780 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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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