RayOne Aspheric RAO600C (REF RAO600/+21.5)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 05029867692277), received between Feb 13, 2020 and Sep 3, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Optical Decentration” (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
- Appropriate Device Problem Term/Code Not Available1
- Optical Decentration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2024Optical Decentration; Optical Decentration
ON 9TH AUGUST 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 THE IOL REQUIRED EXPLANTATION DUE TO BEING "DISPLACED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20124943 ↗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 MULTIPLE EVENTS THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE ASPHERIC RAO600C. THE EVENT DESCRIPTION PROVIDED STATES THAT ONE DAY POST-OPERATIVELY, THE PATIENT PRESENTED WITH FIBRIN REACTION.
Patient problems: No Code Available
MAUDE report 9705845 ↗
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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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