TECNIS IOL DIU375 (REF DIU375U160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 16.0D CYL3.75 · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474748231), received between Sep 27, 2021 and May 26, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCHANGE OF A PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL). FOLLOWING IMPLANTATION, THE PATIENT DEMONSTRATED PERSISTENT OR INCREASED ASTIGMATISM COMPARED TO THE PREOPERATIVE CONDITION, DESPITE THE LENS BEING ALIGNED ON THE INTENDED AXIS. THE PHYSICIAN REFERRED THE PATIENT FOR A SECOND OPINION AND SUSPECTED A POTENTIAL DEVICE ISSUE, INCLUDING INCORRECT POWER OR POSSIBLE MANUFACTURING DEFECT, AS THE EXPECTED REFRACTIVE CORRECTION WAS NOT ACHIEVED AND THE AXIS REMAINED UNCHANGED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 25285773 ↗InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE DIU375 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT STATED THAT THEY ARE UNABLE TO VIEW UP CLOSE PRINT OR SIGNS. PATIENT ALSO SEE FLOATERS, HAS BLURRED VISION, AND USES EYE DROPS. PATIENT REQUESTED NO FOLLOW-UP CALLS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Visual Disturbances; Vitreous Floaters
MAUDE report 19639927 ↗MalfunctionSep 27, 2021Break; Break
IT WAS REPORTED THAT A DIU375 MODEL INTRAOCULAR LENS(IOL) HAD A CHIP IN IT. PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS. SUSPECT PRODUCT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12537370 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.