CLARIFLEX CLRFLXC (REF CLRFLXC155)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SIL 13.0MM 6 OPT MOD C PMMA OPTIEDGE II · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474501461), received between Apr 27, 2023 and Apr 27, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Discolored” (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
- Material Discolored1
Patient problems
- Blurred Vision1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2023Material Discolored; Material Discolored
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DUE TO BLURRY VISION AS A RESULT OF THE IOL BEING CLOUDY. THE PATIENT'S REPORTED VISUAL ACUITY WAS 1.2. POSTOPERATIVELY, THE PATIENT'S VISION WAS STATED AS BEING GOOD WITH NO PROBLEMS. SUTURES WERE REQUIRED, BUT THERE WAS NO REPORTED HEALTH DAMAGE AFTER SURGERY. THE REPLACEMENT IOL MODEL IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 16828089 ↗
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.
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