CLARIFLEX CLRFLXC (REF CLRFLXC240)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 05050474501638), received between Jan 8, 2025 and Jan 8, 2025 — 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
- Foreign Body Sensation in Eye1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2025Material Opacification; Material Opacification
A PATIENT WHO HAD CLARIFLEX LENSES IMPLANTED IN BOTH RIGHT (OD) AND LEFT (OS) EYES IN 2009 REPORTED OF EXPERIENCING SIGNIFICANT VISION ISSUES DUE TO DEPOSITS THAT HAVE FORMED ON THE INTRAOCULAR LENSES (IOLS). THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES OF PATIENT. THE LENSES REMAIN IMPLANTED. ON (B)(6) 2009 (ONSET): THE PATIENT STATES OS VISUAL ACUITY (VA) SEEMS GREAT. FEELS LIKE FOREIGN BODY (FB) AND LITTLE FLICKERY. MANIFEST REFRACTION -1.25 + 0.50 X 130, 20/30. VISUALLY SIGNIFICANT CATARACT (VSC): 20/50 -2, PINHOLE (PH) 20/40. ON (B)(6) 2009: THE PATIENT STATES VA IS CLEARER IN BOTH EYES (OU), COMPLAINT OF LEFT EYE (OS) HAVING A FOREIGN BODY SENSATION (FBS) ON OUTER EDGE AT TIMES. WITHOUT CORRECTION VA <20/25-1; 20/60-2, PH 20/30-2 WITHOUT CORRECTION J-2. SLE (SLIT LAMP EVALUATION) MINOR FOLDS. MEDS AS DIRECTED FOR BOTH EYES (SYSTANE ULTRA TEARS). AS A RESULT, THE PATIENT IS SCHEDULED FOR A PROCEDURE TO EXCHANGE THE IOLS AND IMPLANT NEW LENSES. A RETINA SPECIALIST IS TO EXCHANGE THE IOLS AND SUTURE IN NEW LENSES. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT PERTAINS TO THE RIGHT EYE (OD) OF THE PATIENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'
Patient problems: Foreign Body Sensation in Eye; Visual Disturbances
MAUDE report 21099450 ↗
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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