TECNIS SIMPLICITY DIB00 (REF DIB00U0060)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SIMPLICITY TECNIS EYHANCE U 06.0D · Class 3 · Implant
All models of TECNIS SIMPLICITY (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474731479), received between Apr 24, 2024 and Oct 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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 Fragmentation1
- Material Split, Cut or Torn1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Mechanical Jam; Material Split, Cut or Torn; Mechanical Jam; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS STUCK IN THE PRELOADED DEVICE AND DID NOT TOUCH THE PATIENT. ONLY THE CARTRIDGE TIP WAS PLACED INSIDE THE PATIENT¿S EYE. HOWEVER, THE LENS WOULD NOT ADVANCE. UPON INSPECTION IT WAS NOTED THAT THE IOL WAS RIPPED IN HALF. THE DOCTOR DID NOT HAVE ANOTHER IOL MODEL DIB00 SO HE USED A ZCB00 MODEL. THIS OCCURRED DURING THE SAME PROCEDURE. THERE WAS NO VITRECTOMY, SUTURES, OR PRESCRIBED MEDICATION REQUIRED. THERE WAS A 5-MINUTE DELAY. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23295531 ↗MalfunctionApr 24, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT A TECNIS EYHANCE INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED BUT WAS MISSING ABOUT 20% OF THE HAPTIC. THE DOCTOR DECIDED THAT THE IOL WAS STABLE ENOUGH TO LEAVE IN BUT THEY COULD NOT FIND THE MISSING PORTION ON THE HAPTIC. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175205 ↗
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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