RayOne Aspheric RAO600C (REF RAO600C/+23.5)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 05029867692314), received between Dec 11, 2019 and May 5, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (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
- Failure to Eject1
- Optical Decentration1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2021Failure to Eject; Failure to Eject
ON 22ND APRIL 2021, 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 THAT ONLY HALF OF THE LENS CAME OUT OF THE INJECTOR NECESSITATING LENS REMOVAL AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11775471 ↗MalfunctionDec 11, 2019Optical Decentration; Optical Decentration
ON 7TH DECEMBER 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 ONE DAY POST-OPERATIVELY "IOL COMPLETED SUBLUXED" NECESSITATING A PARS PLANA VITRECTOMY.
Patient problems: Blurred Vision
MAUDE report 9449647 ↗
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page