TECNIS SIMPLICITY DCB00 (REF DCB0000090)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SMPLCTY TECNIS 1PC CLR MONO 9.0D · 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 05050474635869), received between Feb 17, 2023 and Dec 2, 2025 — 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
- Crack1
- 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.
MalfunctionDec 2, 2025Crack; Crack
IT WAS REPORTED THAT DURING THE INSERTION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE EYE, THE CARTRIDGE CRACKED. THERE WAS PATIENT CONTACT WITH THE DEVICE. IT IS UNKNOWN IF A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. THE INCIDENT DID NOT RESULT IN PATIENT INJURY, SUCH AS A CAPSULE TEAR, THOUGH A SUTURE WAS REQUIRED. NO MEDICATIONS WERE PRESCRIBED, AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23698227 ↗MalfunctionJul 8, 2025Break; Break
IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS TWISTED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER IOL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22449690 ↗MalfunctionFeb 17, 2023Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS SCRATCHED. THE LENS HAD A CREASE IN IT WHEN IT WAS PUT INTO THE PATIENT'S RIGHT EYE. THE LENS WAS REMOVED AND REPLACED WITH A NEW LENS IN THE SAME PROCEDURE. THERE WAS NO PATIENT HARM. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16401439 ↗
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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