CLARIFLEX CLRFLXC (REF CLRFLXC185)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 05050474501522), received between Feb 11, 2021 and Feb 11, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Opacification” (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 Opacification1
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.
InjuryFeb 11, 2021Material Opacification; Material Opacification
IT WAS INITIALLY REPORTED THAT A PATIENT RECEIVED AN INTRAOCULAR LENS (IOL) IMPLANT IN THE RIGHT EYE ON (B)(6) 2007 AND WAS RECENTLY EXAMINED. THE DOCTOR OBSERVED WHITE DEPOSITS WITHIN THE IOL. HE WAS SURE THEY ARE IN THE IOL BECAUSE HE ATTEMPTED TO YAG (YTTRIUM-ALUMINUM GARNET) THEM OFF AND THEY COULD NOT BE MOVED. THE CAPSULE WAS OPENED. FURTHER INFORMATION WAS LATER PROVIDED, THE PATIENT CAME IN FOR A FOLLOW UP AND COMPLAINED OF BLURRED VISION. IT WAS INDICATED THAT THE SYMPTOMS HAD BEEN PRESENT FOR AT LEAST SIX (6) MONTHS. UPON EVALUATION, THE DOCTOR OBSERVED WHITE DEPOSITS WITHIN THE LENS. THE EVENT WAS OBSERVED BY THE DOCTOR IN (B)(6) 2020. AT FIRST, THE DOCTOR THOUGHT THAT THE ISSUE WAS POSTERIOR CAPSULE OPACIFICATION (PCO), BUT DURING THE YAG WHICH WAS PERFORMED AT THE END OF (B)(6) 2020, IT WAS APPARENT THAT THE IOL HAD DEPOSITS AND WERE NOT BEING MOVED BY THE YAG. THE DOCTOR INDICATED THAT DURING THE YAG, HE COULD TELL THAT THE POSTERIOR CAPSULE WAS OPENED AND THAT THE DEPOSITS WERE NOT RELATED TO THE CAPSULE. THE ACUITY IN THE AFFECTED EYE IS 20/40. IT WAS REPORTED THAT THE PATIENT IS STILL FUNCTIONAL AND CAN PERFORM THEIR DAILY ACTIVITIES SUCH AS DRIVING. THE PATIENT HA
Patient problems: Blurred Vision
MAUDE report 11319196 ↗
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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