CLARIFLEX CLRFLXBRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SIL 13.5MM 6 OPT MOD C PMMA OPTIEDGE · Class 3 · Implant
Data updated Oct 18, 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 05050474501324), received between May 8, 2026 and May 8, 2026 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Deposits1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO INTRAOCULAR LENSES (IOLS) IN THE LEFT EYE (PIGGYBACK CONFIGURATION) EXPERIENCED PROGRESSIVE VISUAL DISTURBANCES, INCLUDING DOUBLE VISION, FLUCTUATING REFRACTION, AND WORSENING VISUAL ACUITY, ULTIMATELY LIMITING CORRECTION WITH BOTH CONTACT LENSES AND GLASSES. THE RIGHT EYE REMAINS ASYMPTOMATIC WITH SATISFACTORY VISION. THE PATIENT REPORTED DEVELOPMENT OF INTERLENTICULAR SCAR TISSUE, FOR WHICH AN YTTRIUM-ALUMINUM-GARNET (YAG) LASER TREATMENT WAS PERFORMED; HOWEVER, THE PROCEDURE WAS INEFFECTIVE AND REPORTEDLY CAUSED LENS SURFACE DAMAGE (ETCHING), WITH SUBSEQUENT SHIFTING OF THE SCAR TISSUE OBSTRUCTING A SIGNIFICANT PORTION OF VISION. THE PATIENT WAS REFERRED TO A RETINA SPECIALIST AND UNDERWENT TWO OUTPATIENT PROCEDURES UNDER GENERAL ANESTHESIA (EXACT DATES AND DETAILS UNKNOWN, APPROXIMATELY IN 2021¿2022 AND SEPTEMBER 2023), DURING WHICH PARTIAL REMOVAL OF THE INTERLENTICULAR MATERIAL WAS ATTEMPTED WITHOUT RESOLUTION OF SYMPTOMS. THE PATIENT LATER EXPERIENCED ACUTE DETERIORATION OF VISION IN THE LEFT EYE, LIMITED TO PERCEPTION OF SHADOWS AND SHAPES, AND WAS INFORMED THAT ONE OF THE IOLS HAD DISLOCATED POSTERIORLY (SPECIFIC LENS UNKNO
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deposits; Visual Disturbances; Visual Impairment
MAUDE report 25127459 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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