TECNIS IOL DIU150 (REF DIU150U180)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 18.0D CYL1.50 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474746503), received between Jul 21, 2022 and Dec 12, 2025 — classified as 5 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 Problem5
Patient problems
- Visual Impairment2
- Blurred Vision1
- Discomfort1
- Eye Injury1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AFTER THE IMPLANTATION OF A SINGLE PIECE PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT EYE, THE IOL WAS EXCHANGED IN A SECONDARY SURGERY. THE REASON FOR THE EXPLANT IS UNKNOWN, HOWEVER, THE ISSUE WAS INITIALLY IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. THE PATIENT'S PRE-OPERATIVE VISION WAS DOCUMENTED AS 20/50 AND POST-OPERATIVE VISION IS UNKNOWN. THERE WERE NO UNPLANNED SURGICAL INTERVENTIONS REQUIRED, SUCH AS VITRECTOMY OR SUTURES. ADDITIONAL MEDICAL ATTENTION WAS NOT REQUIRED, HOWEVER IT IS UNKNOWN IF ANY MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. IT IS UNKNOWN IF THE ISSUE SIGNIFICANTLY AFFECTED THE PATIENT¿S DAILY ACTIVITIES. DIRECTIONS FOR USE WERE FOLLOWED. PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 23791064 ↗InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED/EXCHANGED FROM THE PATIENT'S RIGHT EYE DUE TO UNDERPOWERED TORIC CORRECTION. IT WAS NOTED THAT THE CORRECT IOL WAS USED BASED ON VERACITY PRE-OP MULTI-VARIATE FORMULA ANALYSIS. THIS WAS REPLACED WITH A DIU300 MODEL IOL SAME DIOPTER POWER AS THE ORIGINAL IOL. THERE WAS NO VITRECTOMY AND NO DELAY IN PROCEDURE REPORTED. IT IS UNKNOWN IF THERE WAS INCISION ENLARGEMENT OR SUTURES REQUIRED. PATIENT OUTCOME UNKNOWN. EXPLANTED IOL DISCARDED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 17915621 ↗InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE NON-PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT HAD RESIDUAL ASTIGMATISM AFTER SURGERY. REPLACED WITH THE DIU225 18.0 HIGHER DIOPTER. THE SUSPECT IOL IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 17873870 ↗InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE DUE TO BLURRY DISTANCE VISION AS THEY¿RE UNABLE TO FOCUS. THE PRE-OPERATIVE VISUAL ACUITY IS WAS 20/60 -1. POST-OPERATIVE VISUAL ACUITY IS 20/40. THE IOL REMOVAL REQUIRED THE INCISION TO BE ENLARGED. THERE WAS NO VITRECTOMY AND NO SUTURES REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 15523763 ↗InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO THE PATIENT BEING UNSATISFIED WITH NEAR VISION. ANOTHER JOHNSON & JOHNSON IOL (DIFFERENT MODEL, ZKB, DIFFERENT DIOPTER, 19.0). THE PATIENT IS FINE AND DOING WELL. THE LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Discomfort
MAUDE report 15080522 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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