TECNIS IOL DIU225 (REF DIU225U140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 14.0D CYL2.25 · Class 3 · Implant
All models of TECNIS IOL (1344)
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 05050474747012), received between Apr 4, 2022 and Mar 28, 2025 — classified as 2 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
- Device Difficult to Setup or Prepare1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Corneal Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2025Break; Break
IT WAS REPORTED BY THE DOCTOR THAT A PRELOADED TORIC LENS WAS EXPLANTED AND A NEW LENS OF THE SAME MODEL WAS IMPLANTED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION REVEALED THAT THERE WAS A KINK AND THE LENS DID NOT CENTER PROPERLY. THEY DO NOT KNOW WHY THE LENS WOULD NOT CENTER PROPERLY. THE LENS WAS REMOVED AND A NEW LENS WAS PLACE ON A DIFFERENT DAY THAN THE INITIAL DAY OF CATARACT REMOVAL AND LENS PLACEMENT. THERE WAS NO ERROR LED TO THIS EVENT. NO INJURY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21724659 ↗MalfunctionApr 4, 2022Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare
IT WAS REPORTED THAT IT WAS NOTED THAT THE INTRAOCULAR LENS (IOL) WAS TIGHT UPON TRYING TO INJECT IT FROM THE CARTRIDGE. ONCE IN THE PATIENT'S RIGHT EYE, A LARGE CENTRAL DEFECT WAS NOTED AND THE LENS HAD TO BE EXPLANTED DURING THE SAME PROCEDURE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO INJURY, BUT JUST REQUIRED LONGER RECOVERY DUE TO MORE CORNEAL EDEMA. THE PATIENT IS NOW FINE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Corneal Edema
MAUDE report 14005451 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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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