TECNIS SIMPLICITY DCB00 (REF DCB0000125)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SMPLCTY TECNIS 1PC CLR MONO 12.5D · Class 3 · Implant
All models of TECNIS SIMPLICITY (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474635937), received between May 6, 2022 and Dec 19, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Scratched Material3
- Crack1
- Ejection Problem1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND SCRATCHED AFTER IT WAS IMPLANTED. THE LENS WAS EXPLANTED DURING THE SAME SURGERY, AND A NON-JOHNSON & JOHNSON LENS WAS USED AS A REPLACEMENT. THE LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23847382 ↗MalfunctionDec 17, 2025Crack; Mechanical Jam; Crack; Mechanical Jam
IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) DID NOT RELEASE THE LENS PROPERLY. THE SURGEON OBSERVED THAT THE TIP OF THE DEVICE DID NOT LOOK AS IT SHOULD. BALANCE SALT SOLUTION (BSS) WAS USED TO PRIME THE DEVICE. ACCOUNT INDICATED THAT THE TIP OF THE CARTRIDGE MADE CONTACT WITH THE PATIENT BUT THE IOL WAS COMPLETELY STUCK INSIDE THE INJECTOR. NO PATIENT INJURY OCCURRED. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE PROCEDURE WAS COMPLETED USING A BACK UP DEVICE WITHOUT FURTHER ISSUE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835004 ↗MalfunctionNov 26, 2025Scratched Material; Scratched Material
IT WAS REPORTED BY THE CUSTOMER THAT AN INTRAOCULAR LENS (IOL) WAS DISCOVERED TO BE SCRATCHED AFTER BEING IMPLANTED IN THE PATIENT'S OPERATIVE EYE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23662929 ↗MalfunctionJul 1, 2025Ejection Problem; Ejection Problem
IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) DID NOT DEPLOY CORRECTLY IN THE OPERATING ROOM. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22379227 ↗MalfunctionFeb 6, 2025Break; Break
IT WAS REPORTED THAT THE PRELOADED LENS HAD A HAPTIC THAT TWISTED INCORRECTLY WHILE ADVANCING OUT OF THE PRELOADED CARTRIDGE, WITH THE CARTRIDGE AND LEADING HAPTIC REMAINING IN THE EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS. NO INJURY OR ADDITIONAL INTERVENTION WAS NEEDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21329448 ↗MalfunctionMar 8, 2024Break; Break
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18867309 ↗MalfunctionApr 26, 2023Scratched Material; Scratched Material
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S RIGHT EYE. IT WAS NOTICED TO BE SCRATCHED AFTER IMPLANTATION. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THE INCISION WAS NOT ENLARGED. REPORTEDLY, THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT'S ACTIVITIES OF DAILY LIFE. THE INJECTOR WAS RETURNED TO THE DISTRIBUTOR. THE LENS WAS NOT INCLUDED IN THE RETURNED PACKAGE. THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16820666 ↗MalfunctionMay 6, 2022Break; Break
A SURGEON REPORTED THAT AFTER INSERTING AN INTRAOCULAR LENS (IOL) INTO THE EYE, THERE WAS A HOLE IN THE LENS WHICH REQUIRED HIM TO CUT THE LENS OUT AND REPLACE IT. THE REMOVED LENS WAS NOT SAVED SINCE IT WAS CUT INTO PIECES IN ORDER TO BE REMOVED. THE PATIENT IS DOING FINE WITH NO ADVERSE EFFECTS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14312591 ↗
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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