TECNIS IOL DIU375 (REF DIU375U275)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 27.5D 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474748460), received between Sep 23, 2021 and Jul 1, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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
- Application Program Problem: Dose Calculation Error1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Unstable1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Corneal Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2025Application Program Problem: Dose Calculation Error; Unstable; Application Program Problem: Dose Calculation Error; Unstable
IT WAS REPORTED THAT A PRE-LOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENTS LEFT EYE DUE TO MISCALCULATION OF DIOPTER POWER. PATIENTS IOL WAS ROTATED AND THAT WAS NOT THE REASON FOR EXPLANT. THE LENS WAS REPLACED WITH ZCU375 29.0 DIOPTER LENS IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. POST PROCEDURE, PATIENT IS HAPPY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22378903 ↗InjurySep 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT A TECNIS EYHANCE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE BECAUSE THE SURGEON BELIEVES THE LENS POWER IS NOT CORRECT. IT WAS INDICATED THAT THE SYMPTOMS WERE NOTICED IMMEDIATELY FOLLOWING THE SURGERY ((B)(6) 2021) AND THAT AT ONE WEEK, THE PATIENT STILL HAD CORNEAL EDEMA. THE SURGEON ALSO REPORTED THAT THE PATIENT HAS RESTING TREMOR AND FLOPPY IRIS. THE REPLACEMENT LENS USED WAS A DIU300, 25 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema
MAUDE report 12524026 ↗
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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