TECNIS IOL DIU375 (REF DIU375U185)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 18.5D CYL3.75 · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474748286), received between Nov 12, 2024 and Dec 9, 2025 — classified as 3 injuries.
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 Problem3
Patient problems
- Eye Injury2
- Visual Impairment2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO REFRACTIVE SURPRISE. ANOTHER JOHNSON AND JOHNSON DIU MODEL IOL WAS IMPLANTED AS REPLACEMENT. IT IS UNKNOWN IF ANY ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT STATUS IS UNKNOWN. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 23759811 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DIU375 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE BEEN IMPLANTED IN THE PATIENT'S EYE AND EXPLANTED OUT. IT IS UNKNOWN IF THE IOL EXPLANT OCCURRED DURING THE SAME PROCEDURE OR A SEPARATE SECONDARY PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Eye Injury
MAUDE report 21972501 ↗InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS EXPLANTED DUE TO UNEXPECTED OUTCOME. IT WAS REPLACED WITH ANOTHER SAME MODEL J&J IOL WITH A LOWER DIOPTER. THE PATIENT'S PRE-OPERATIVE VISION WAS 20/40 AND POST-OPERATIVE VISION IMPROVED TO 20/60. THE PATIENT IS DOING WELL AND HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury; Visual Impairment
MAUDE report 20669011 ↗
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.