RayOne Spheric RAO100C (REF RAO100C/+23.0)Recalls & reported problems
Rayner Intraocular Lenses Limited · Class 3 · Implant
Data updated Oct 18, 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 05029867689666), received between Aug 4, 2025 and Aug 19, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2025Break; Break
ON 5TH AUGUST 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILTIY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE SPHERIC RAO100C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS WAS BROKEN IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE NECESSITATING LENS EXPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22837235 ↗MalfunctionAug 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON (B)(6) 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE SPHERIC RAO100C. THE EVENT DESCRIPTION PROVIDED STATES THAT THE IOL TORE DURING INJECTION NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22697684 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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