TECNIS IOL DIU150 (REF DIU150U230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474746602), received between Jul 23, 2021 and Aug 11, 2025 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIU150 MODEL INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT¿S OCULAR SINISTER (LEFT EYE) DURING THE SAME PROCEDURE TO PLACE A 3-PIECE LENS AFTER BEING FULLY INSERTED. VITRECTOMY, YAMANI TECHNIQUE TO SECURE THE 3-PIECE LENS, SUTURES, AND A ONE (01) HOUR PROCEDURAL DELAY WERE REPORTED DURING THE INITIAL SURGERY HOWEVER, IT IS UNKNOWN IF THE INCISION WAS ENLARGED. THERE WAS NO MEDICAL ATTENTION AND NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE). THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778863 ↗
• MalfunctionJun 2, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL LENS HAD A SCRATCH NOTED BY THE SURGEON ONCE IT WAS IMPLANTED. THE SURGEON CUT OUT THE LENS WITHOUT ENLARGING THE INCISION AND THEN IMPLANTED THE BACKUP LENS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128641 ↗
• InjuryJun 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIU150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY, THE PATIENT HAD MYOPIC/REFRACTIVE SURPRISE CAUSING SYMPTOMATIC IMPAIRMENT OF VISUAL FUNCTION AND NOT CORRECTABLE WITH A TOLERABLE CHANGE IN GLASSES OR CONTACTS. THE IOL WAS INTERFERING WITH THE PATIENT'S DAILY LIFE ACTIVITIES. IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED AND REPLACED WITH A DIU150 22.5 IOL. THERE WAS NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY HOWEVER THE INCISION WAS ENLARGED FROM 2.4MM TO 2.7MM FOR A TWIST AND OUT TECHNIQUE DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXPLANT WAS REPORTED AS GOOD PROGNOSIS AND 20/20 VISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22121265 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO SUBJECTIVE VISUAL DISTURBANCE (TEMPORAL NEGATIVE DYSPHOTOPSIA).IT WAS REPLACED WITH A NON JNJ LENS. THERE WAS NO PATIENT INJURY. THERE WERE SUTURES REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 20884745 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE EYE PATIENT'S LEFT EYE, THE PATIENT WAS NOT HAPPY WITH OVERALL DISTANCE VISION AND THERE MAY BE A NEED FOR EXPLANT, HOWEVER THE SURGEON WANTED TO WAIT TO SEE IF THE DISTANCE VISION IMPROVED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE IOL WAS EXPLANTED IN A SECONDARY SURGERY FROM THE PATIENT'S LEFT EYE DUE TO THE PATIENT HAVING A TOUGH TIME ADJUSTING DUE TO ANISOMETROPIA RESULTING FROM REFRACTIVE POWER BETWEEN EYES. THE ISSUE WAS FIRST IDENTIFIED IN A POST-OPERATIVE EXAMINATION.THERE WAS NO CALCULATION ISSUE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIU150 +22.0 DIOPTER). THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 20845866 ↗
• MalfunctionJun 19, 2024Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  AFTER FULL IMPLANTATION OF THE DIU150 MODEL INTRAOCULAR LENS (IOL) IN THE PATIENT'S EYE, IT WAS OBSERVED THAT THE TRAILING HAPTIC HAD BECOME LODGED BEHIND THE PLUNGER, RESULTING IN DETACHMENT/AMPUTATION OF THE BACK HAPTIC. A BACK-UP LENS, DIU150 24.0 DIOPTER IOL, WITH THE SAME MODEL BUT DIFFERENT DIOPTER SIZE WAS IMPLANTED INTO THE PATIENT'S OCULAR SINISTER (LEFT EYE). THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, AND NO VITRECTOMY. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570596 ↗
• InjuryNov 17, 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 FROM THE PATIENT'S RIGHT EYE DUE TO UNINTENDED MYOPIA. THE PATIENT THOUGHT HIS VISION WOULD BE BETTER BY THIS POINT, SEES BROWN SPOT. THIS WAS REPLACED WITH THE SAME MODEL IOL, BUT A LOWER DIOPTER POWER (22.5D). THE EXPLANTED IOL WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment; Vitreous Floaters

  MAUDE report 18157570 ↗
• InjuryJul 20, 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 DUE TO BLURRY VISION. THERE WAS NO DELAY IN PROCEDURE, NO MEDICAL INTERVENTION, NO INCISION ENLARGEMENT, NO SUTURES, AND NO VITRECTOMY REPORTED. HYPEROPIC SURPRISE ORA WAS USED. PATIENT OUTCOME: 20/30 VISION HYPEROPIC OUTCOME +1.25. VISUAL ACUITY PRE-OPERATIVE: 20/25. VISUAL ACUITY POST-OPERATIVE: 20/30. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17368250 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS NOT USED. THIS IOL DID TOUCH THE PATIENT AND THERE WAS A MALFUNCTION DURING INSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656682 ↗
• MalfunctionJan 30, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) DID NOT LOOK OR FEEL RIGHT IN INSERTER PER DOCTOR. NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16268791 ↗
• InjuryNov 4, 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 RIGHT EYE AS THE PATIENT CONTINUED TO HAVE POOR VISUAL ACUITY AND WAS ONLY CORRECTABLE TO A POOR 20/30. THE IOL APPEARED TO BE IN GOOD POSITION AND THE EYE RESPONDED WELL. THERE WAS NO EXPLANATION FOUND. VISION PRE-OPERATIVE: 20/40, VISION POST-OPERATIVE: 20/70. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED, HOWEVER, THE INCISION WAS ENLARGED. MEDICATION WAS PRESCRIBED. THE REPLACEMENT LENS INFORMATION WAS NOT PROVIDED. THE PATIENT HAS FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15738036 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO A REFRACTIVE SURPRISE. ACCOUNT PROVIDED THAT THE IOL WAS REPLACED AND SUTURES WERE PLACED. THE PATIENT WAS DOING GOOD POST-OPERATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 13182995 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE LEFT EYE AND REMOVED DURING THE SAME-PROCEDURE AS THE CAPSULE BROKE. ANOTHER JOHNSON & JOHNSON LENS (ZA9003 MODEL, 22.5 DIOPTER) WAS IMPLANTED; HOWEVER, THAT LENS WAS ALSO REMOVED AS AN ANTERIOR CHAMBER (AC) LENS WAS REQUIRED. A VITRECTOMY WAS PERFORMED AND THE SURGERY WAS COMPLETED USING AN AC LENS. THE PATIENT IS DOING FINE POST-OPERATIVELY AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12285412 ↗
• MalfunctionJul 23, 2021Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) MALFUNCTIONED. THERE WAS CONTACT WITH PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222336 ↗