TECNIS SIMPLICITY DIB00 (REF DIB00U0075)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SIMPLICITY TECNIS EYHANCE U 07.5D · Class 3 · Implant
All models of TECNIS SIMPLICITY (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474731509), received between Jan 30, 2025 and Mar 17, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Scratched Material
A SCRATCH ON THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS NOTED AFTER ITS IMPLANTATION IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE) THE IOL WAS REMOVED BY CUTTING IT INTO PIECES AND WAS REPLACED USING A BACK-UP DIB00 7.5 IOL DURING THE SAME PROCEDURE. THERE WAS NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY HOWEVER, PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24624009 ↗MalfunctionJan 8, 2026Break
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. THE SURGEON NOTED A CRACK IN THE LENS OUTSIDE OF THE VISUAL AXIS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24000262 ↗MalfunctionJan 30, 2025Break; Break
IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED AND THE HAPTIC WAS BROKEN. THE IOL CAME OUT OF THE INJECTOR THIS WAY AND NOT DUE TO INSERTION. THE LENS WAS CUT OFF AND REMOVED FROM THE PATIENT'S OPERATIVE EYE. ANOTHER LENS WAS INSERTED AS A REPLACEMENT. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION OUTSIDE THE STANDARD OF CARE WAS PERFORMED. THE LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21280206 ↗
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