TECNIS IOL DIU150 (REF DIU150U135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474746411), received between Aug 8, 2023 and May 29, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Crack

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON (JNJ) INTRAOCULAR LENS (IOL). WHILST ADVANCING LENS IT POPPED OUT THE SIDE OF THE INSERTER. THE IOL WAS INSERTED AND THEN REMOVED DURING THE SAME PROCEDURE. THE PATIENT WAS NOT INJURED AND HAS FULLY RECOVERED. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT¿S DAILY ACTIVITIES ARE NOT AFFECTED BY THIS EVENT. THERE WAS NO VITRECTOMY, SUTURES OR DELAY IN THE PROCEDURE. AND NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340707 ↗
• MalfunctionMay 29, 2026Crack

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON (JNJ) INTRAOCULAR LENS (IOL). WHILST ADVANCING LENS IT POPPED OUT THE SIDE OF THE INSERTER. THE IOL WAS INSERTED AND THEN REMOVED DURING THE SAME PROCEDURE. THE PATIENT WAS NOT INJURED AND HAS FULLY RECOVERED. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT¿S DAILY ACTIVITIES ARE NOT AFFECTED BY THIS EVENT. THERE WAS NO VITRECTOMY, SUTURES OR DELAY IN THE PROCEDURE. AND NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340705 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WORSENING VISION IN BOTH EYES FOLLOWING IMPLANTATION OF PRELOADED MONOFOCAL TORIC INTRAOCULAR LENSES (IOLS). THE PATIENT REPORTED SIGNIFICANT LIGHT SENSITIVITY, PARTICULARLY AT NIGHT WHILE DRIVING, WITH HEADLIGHTS CAUSING SEVERE IRRITATION, AS WELL AS PERSISTENT DOUBLE VISION AND POOR DISTANCE VISION IN THE RIGHT EYE. THE PATIENT STATED THAT THESE SYMPTOMS BEGAN IMMEDIATELY AFTER THE SURGICAL PROCEDURES, ALTHOUGH THE EXACT SURGERY DATES WERE NOT PROVIDED. THE PATIENT ALSO REPORTED EXPERIENCING STARBURST EFFECTS PRIOR TO SURGERY; HOWEVER, FOLLOWING CATARACT SURGERY, THE STARBURSTS BECAME SIGNIFICANTLY BRIGHTER AND MORE PRONOUNCED, INCREASING SUBJECTIVELY FROM APPROXIMATELY FIVE TO FIFTY STARBURSTS, DESCRIBED AS CLEARER AND MORE VIBRANT. THE PATIENT WAS PRESCRIBED EYE DROPS, INCLUDING PREDNISOLONE ACETATE, BEGINNING ON MARCH 18, 2026, WHICH REPORTEDLY IMPROVED PAIN AND LIGHT SENSITIVITY. DURING A FOLLOW UP VISION EVALUATION ON MARCH 25, 2026, THE PATIENT CONTINUED TO REPORT POOR VISION AND DOUBLE VISION IN THE RIGHT EYE, WHILE THE LEFT EYE WAS REPORTED TO HAVE GOOD VISION. THE PHYSICIAN INITIALLY SUGGESTED THAT THE INTRAOCULAR LENS IN THE

  Patient problems: Blurred Vision; Flashers; Visual Disturbances; Visual Impairment

  MAUDE report 24918610 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD), THE PATIENT LEFT THE PROCEDURE FEELING FINE AND THEN CAME BACK WITH AN INFECTION. ABOUT FOUR TO FIFTEEN DAYS AFTER THE PROCEDURE, THE PATIENT BEGAN TO FEEL DISCOMFORT, INCREASED IRRITATION, INFLAMMATION AND INFECTION. A CULTURE WAS COLLECTED AND WAS NEGATIVE FOR GROWTH. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT¿S OD DISTANCE VA WITH CORRECTION (CC) WAS 20/25 PRE IMPLANT (BRIGHTNESS ACUITY TEST (BAT) TO 20/50-2) ON (B)(6) 2023. ON (B)(6) 2023, PRIOR TO THE IMPLANTATION OF THE LENS, THE PATIENT¿S VA WAS 20/40 -2 (UNKNOWN IF CORRECTED OR UNCORRECTED). THE PATIENT'S VA AFTER THE IMPLANTATION OF THE LENS WAS 20/20-2 (ON (B)(6) 2023). IT IS UNKNOWN IF THE PATIENT'S DAILY ACTIVITIES WERE AFFECTED. MEDICAL INTERVENTION OF TAP/INJECTION WAS PERFORMED ON (B)(6) 2023. THE INTRAOCULAR PRESSURE (IOP) WAS 12 IN RIGHT EYE (OD) PRIOR TO TAP (ON (B)(6) 2023). AFTER TAP, IOP WAS 49. THE PATIENT WAS GIVEN DIAMOX 500MG AND COSOPT/ALPHAGAN AND THE PATIENT WAS STARTED ON LEVAQUIN ORAL 500MG/DAY X 10 DAYS. PRIOR TO THE PATIENT LEAVING, IOP WAS 23. IT IS UNKNOWN IF THE ELEVATED IOP LASTED LONGER T

  Patient problems: Blurred Vision; Conjunctivitis; Eye Infections; Eye Pain; Inflammation; Intraocular Pressure Increased; Red Eye(s)

  MAUDE report 17927666 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED THAT A MONOFOCAL TORIC PRELOADED INTRAOCULAR LENS (IOL) WAS OPENED ON THE SURGERY FIELD BUT NOT USED BECAUSE IT WAS BROKEN. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483814 ↗