CLARIFLEX CLRFLXC (REF CLRFLXC200)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474501553), received between Oct 21, 2024 and Oct 21, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Material Opacification1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2024Material Opacification; Material Opacification
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IMPLANTED IN (B)(6) 2009 WAS EXPLANTED ON (B)(6) 2024. DURING TESTING, THE LENS EXHIBITED CLOUDINESS, WHICH EVENTUALLY EXTENDED TO THE CENTER OF THE OPTICAL SECTION. THE PATIENT HAS DIABETES MELLITUS, AND HAS NOT UNDERGONE VITRECTOMY OR YTTRIUM ALUMINUM GARNET (YAG) LASER TREATMENT. ACCOUNT INDICATED THAT DESPITE BEING A SILICONE LENS, THE IOL SHOWED SYMPTOMS SIMILAR TO GLISTENING. THEREFORE, THE IOL WAS EXPLANTED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20501162 ↗
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