TECNIS SIMPLICITY DCB00 (REF DCB0000075)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SMPLCTY TECNIS 1PC CLR MONO 7.5D · Class 3 · Implant
All models of TECNIS SIMPLICITY (112)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474635838), received between Dec 14, 2022 and Jul 3, 2025 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
- Mechanical Jam2
- Adverse Event Without Identified Device or Use Problem1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Intraocular Pressure Increased1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2025Break; Mechanical Jam; Break; Mechanical Jam
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS STUCK IN CARTRIDGE AND RESULTED IN IOL DAMAGED. IOL WAS NOT USED AND DID NOT TOUCH THE PATIENT'S EYE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394443 ↗MalfunctionJun 13, 2025Break; Mechanical Jam; Break; Mechanical Jam
IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) BECAME STUCK INSIDE THE INJECTOR AND WAS SUBSEQUENTLY EJECTED IN A DAMAGED STATE. THE TIP OF THE CARTRIDGE WAS IN CONTACT WITH THE PATIENT'S EYE. A REPLACEMENT IOL WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22207971 ↗InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR MONOFOCAL LENS WAS REMOVED DUE TO INCREASED INTRAOCULAR PRESSURE. THE LENS WAS REMOVED AFTER ONE HOUR AND REPLACED WITH A TORIC LENS, AS THE PATIENT HAD COME TO THE THEATRE AFTER ONE HOUR. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Intraocular Pressure Increased
MAUDE report 22188043 ↗MalfunctionFeb 10, 2025Break; Break
IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FAULTY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21346213 ↗MalfunctionOct 31, 2024Break; Break
IT WAS REPORTED THAT WHEN USING THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON NOTED THAT THE LOOP WAS BROKEN. THE ISSUE WAS OBSERVED BEFORE IMPLANTATION, DURING HANDLING/PRIOR TO INSERTION INTO THE PATIENT'S EYE. THEREFORE, THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20583090 ↗MalfunctionJul 15, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT AFTER IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL) A DEFECT WAS NOTICED ON THE SURFACE OF THE LENS. THE IOL WAS REPLACED WITH A LENS OF THE SAME MODEL / DIOPTER. THE INITIAL LENS WAS DISCARDED. THE PATIENT IS DOING WELL. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19744980 ↗MalfunctionMar 20, 2024Break; Break
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED AND NOT IMPLANTED. THE SURGEON TOOK IT OUT OF THE BOX AND SAID THAT IT LOOKED DAMAGED. THERE WAS NO PATIENT CONTACT. IT WAS NOTED THAT THE INCIDENT OCCURRED IN FEBRUARY. THERE WAS NO APPARENT DAMAGE ON THE IOL BOX NOR THE OUTER SHIPPING BOX. THE ISSUE WAS NOT DUE TO USE ERROR. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18942775 ↗MalfunctionDec 14, 2022Break; Break
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. ACCOUNT INDICATED THAT THERE WAS NO PATIENT CONTACT WITH THE PRODUCT AS ISSUE WAS OBSERVED UPON OPENING THE PACKAGING AND THE IOL WAS NOT USED. THE IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15979242 ↗
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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