TECNIS IOL DIU150 (REF DIU150U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474746527), received between May 13, 2021 and May 7, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED ENDOPHTHALMITIS FOLLOWING IMPLANTATION OF A PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE SURGERY ON (B)(6) 2026 WAS UNCOMPLICATED; HOWEVER, THE PATIENT PRESENTED ON (B)(6) 2026 WITH ONE DAY OF DECREASED VISION, AND EXAMINATION WAS CONCERNING FOR ACUTE ENDOPHTHALMITIS, WITH TAP AND INJECT PERFORMED AND CULTURE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS. THE PROCEDURE INVOLVED NO TRYPAN BLUE OR IRIS EXPANSION DEVICES, AND INTRACAMERAL EPISHUGARCAINE WAS USED; MANAGEMENT INCLUDED MULTIPLE TAP AND INJECT PROCEDURES AND PARS PLANA VITRECTOMY (PPV), WITH TOPICAL AND INTRAOCULAR TREATMENTS ADMINISTERED AND NO SYSTEMIC OR SUBCONJUNCTIVAL THERAPY REQUIRED. NO INCISION ENLARGEMENT OR SUTURES WERE PERFORMED; AT FOLLOW-UP ON (B)(6), 2026, VISION WAS STABLE, THE PATIENT REMAINS IN EARLY POSTOPERATIVE RECOVERY, AND THE LENS REMAINS IMPLANTED. ADDITIONALLY, IT WAS LEARNED THAT THERE WERE TWO CASES OCCURRING WITHIN ONE WEEK, BOTH AS THE FIRST CASE OF THE DAY IN THE SAME OPERATING ROOM; FOR THE REPORTED CASE, THE PATIENT WAS THE FIRST SURGERY OF THE DAY, FOLLOWED BY ADDITIONAL PROCEDURES, WITH NO OTHER SIMILAR INCIDENTS REPORTED ON THA

  Patient problems: Endophthalmitis

  MAUDE report 25119742 ↗
• MalfunctionJan 29, 2026Crack

  IT WAS REPORTED BY THE CUSTOMER THAT DURING IMPLANTATION, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIU150, EXPERIENCED A CARTRIDGE FRACTURE. THE LENS MADE CONTACT WITH THE PATIENT; HOWEVER, NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215263 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF THE PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, A REFRACTIVE CHANGE WAS NEEDED FOR THE PATIENT. THE PATIENT WANTED DISTANCE AND TORIC ROTATION AND REPORTED LOSS OF DEPTH PERCEPTION THAT INTERFERED WITH DAILY ACTIVITIES. THE IOL WAS SUBSEQUENTLY EXPLANTED IN A SECONDARY PROCEDURE. NO UNPLANNED INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THE PATIENT DID NOT SEEK FURTHER MEDICAL ATTENTION AND DID NOT RECEIVE ANY MEDICATION OUTSIDE THE STANDARD OF CARE. THE DIRECTIONS FOR USE WERE FOLLOWED. THE REPORTED OUTCOME WAS TEMPORARY IMPAIRMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 23653067 ↗
• InjuryMar 19, 2025Adverse 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 DUE TO OVERCORRECTED ASTIGMATISM. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS NO CALCULATION ISSUE. THERE WAS NO USE ERROR. THE PATIENT'S OUTCOME IS IMPROVED. THE SYMPTOMS DID NOT INTERFERE WITH PATIENT'S DAILY ACTIVITIES AND FEELS WERE BETTER NOW. THE REPLACED LENS HAD SATISFIED/CORRECTED THE PATIENT¿S ASTIGMATISM. THERE WEE NO DEBILITATING CONDITIONS NOW. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21647764 ↗
• MalfunctionMar 15, 2024Material Opacification; Material Opacification

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A WRAPPING BUBBLE IN MIDDLE OF THE IOL. THE LENS WAS FULLY INSERTED INTO THE PATIENT¿S LEFT EYE AND WAS REMOVED. A BACKUP LENS OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT IS DOING FINE AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18916468 ↗
• MalfunctionSep 18, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE TORIC INTRAOCULAR LENS (IOL) WAS INSERTED INT THE PATIENT¿S LEFT EYE, IT WAS NOTED THERE WAS AN INDENTATION, IMPERFECTION IN THE CENTER OF OPTIC. THE LENS WAS REMOVED DURING SAME PROCEDURE AND A BACKUP LENS OF THE SAME MODEL AND DIOPTER WAS INSERTED. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THE PATIENT IS HAPPY WITH THE OUTCOME AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770147 ↗
• MalfunctionJun 16, 2023Break; Break

  IT WAS REPORTED THAT THE DIU150 INTRAOCULAR LENS BACK HAPTIC GOT BENT DURING HANDLING BEFORE PATIENT CONTACT. THE INNER POUCH WAS NOT OPENED/UN-SEALED WHEN RECEIVED. ADDITIONAL INFORMATION REVEALED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DIU150 LENS. THERE WAS NO USE ERROR DURING HANDLING. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144958 ↗
• InjuryFeb 24, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED UPON INSERTION THE TRAILING HAPTIC OF THE DIU150 INTRAOCULAR LENS (IOL) WAS STUCK IN THE CARTILAGE. THE DOCTOR DID A MANUAL LENS REMOVAL OF THE IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440055 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH BILATERAL IMPLANTS OF THE TECNIS EYHANCE INTRAOCULAR LENSES (IOLS) IS COMPLAINING OF SHADOWING. THE PATIENT REPORTED THAT THE IMAGES ALL LOOK SHADOWED. THE SURGEON DID HIS BEST TO ASSIST THE PATIENT, BUT IS NOW PLANNING TO EXPLANT ONE OF THE LENSES. THE PATIENT IS -0.70, 20/30 -2 IN ONE OF THE EYES WITH DISTANCE ISSUES. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS IN THE LEFT (OS) EYE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON ZCU150 LENS (DIFFERENT MODEL AND LOWER DIOPTER). AT ONE DAY POST-OPERATIVE (OP), UNCORRECTED VISUAL ACUITY (UCVA) IS 20/30. THE RIGHT EYE REMAINS IMPLANTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS LEFT EYE. A SEPARATE REPORT WILL NOT BE FILED FOR THE RIGHT EYE AS THE LEFT EYE WAS THE ONLY EYE THAT UNDERWENT AN EXCHANGE.

  Patient problems: Discomfort; Visual Disturbances

  MAUDE report 12456451 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT DIU150 MODEL INTRAOCULAR LENS (IOL) LEADING HAPTIC CAME OUT TWISTED. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822357 ↗