TECNIS IOL DIU375 (REF DIU375U140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 14.0D CYL3.75 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474748194), received between Aug 27, 2025 and Oct 16, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Fold, Unfold or Collapse1
Patient problems
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
THE TECHNICIAN ADVANCED THE PLUNGER OF THE DIU375 MODEL INTRAOCULAR LENS (IOL) AND IT FELT OK, BUT NOT SURE. THE LENS WAS SUBSEQUENTLY HANDED TO THE DOCTOR, WHO PROCEEDED TO ADVANCE IT INTO THE PATIENT¿S EYE. IT WAS NOTED THAT THE TRAILING HAPTIC WAS NOT POSITIONED ON THE OPTIC AS ANTICIPATED BUT WAS INSTEAD STRAIGHT WITHIN THE CARTRIDGE BARREL. THE DOCTOR UTILIZED A GRASPER TO REMOVE THE HAPTIC FROM THE INJECTOR AND SUCCESSFULLY PLACED THE IOL INTO THE POSTERIOR CAPSULE. THE LENS WAS UNDAMAGED, AND THERE WAS NO HARM TO THE PATIENT¿S EYE. NO PATIENT INJURY WAS REPORTED DURING THE PROCEDURE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23318939 ↗InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS WAS WASTED DUE TO CAPSULE RUPTURE. ADDITIONAL INFORMATION INDICATED THAT THE DETAILS WERE NOT RECORDED AND THE LENS WAS DISPOSED BY CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Capsular Bag Tear
MAUDE report 22908944 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page