TECNIS IOL DIU150 (REF DIU150U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474746558), received between Mar 4, 2022 and Mar 23, 2026 — classified as 4 injuries, 6 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. 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.

• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT UPON OPENING THE PRODUCT PACKAGING, THE PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL), MODEL DIU150, WAS FOUND TO BE MALFUNCTIONING. NO PATIENT CONTACT OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663915 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) WAS INSERTED INTO A PATIENT'S OPERATIVE EYE AND FOUND TO BE CRACKED IN HALF. CONSEQUENTLY, THE SURGEON REMOVED THE DAMAGED LENS AND REPLACED IT WITH A NEW ONE. IT IS UNKNOWN IF ANY ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780383 ↗
• InjuryDec 4, 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 SINISTER (LEFT EYE). DUE TO PATIENT COMPLAINTS OF DIFFICULTY WITH GLARE AND BLURRED VISION WHILE DRIVING AT NIGHT, AND DIFFICULTY WITH READING, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE; REPLACEMENT IOL INFORMATION IS UNKNOWN. THERE ARE NO DAILY ACTIVITIES THAT THE PATIENT CANNOT PERFORM THAT HE WAS ABLE TO PRIOR TO THE SURGERY. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), NO PROCEDURAL DELAYS, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 20/40+1 AND POST OPERATIVE WAS 20/25+1. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23723925 ↗
• MalfunctionNov 20, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS IMPLANTED AND THE SURGEON NOTICED THAT THE TORIC EYHANCE SHIFTED ALMOST 90 DEGREES. ADDITIONAL INFORMATION SUGGESTED THAT THE PATIENT WAS SEEING WELL UNTIL ONE WEEK POST-OP BUT THEN WOKE UP ONE MORNING WITH "DRASTICALLY WORSE VISION." ON POD1 (ON (B)(6) 2024), THE PATIENT HAD AN UNCORRECTED VISION OF 20/40; ON POW1 (ON (B)(6) 2024), THE UNCORRECTED VISION IMPROVED TO 20/30. THE PATIENT CAME IN ON (B)(6), COMPLAINING THAT THEIR VISION WORSENED THE DAY PRIOR, AND FOUND TO HAVE AN UNCORRECTED VISION OF 20/240. THE TORIC MARKER WAS AT 90 DEGREES AWAY FROM THE IMPLANTED POSITION. THE PATIENT REQUIRED ONE REPOSITIONING AND HAD 20/20 UNCORRECTED VISION ON POD1 AFTER THE REPOSITIONING. NO INJURY OR MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 20737106 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE PATIENT WASN¿T SEEING AS WELL AS EXPECTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 18234093 ↗
• MalfunctionFeb 14, 2023Crack; Operating System Becomes Nonfunctional; Scratched Material; Crack; Operating System Becomes Nonfunctional; Scratched Material

  IT WAS REPORTED THE DIU150 INTRAOCULAR LENS (IOL) WAS DAMAGED UPON INSERTION. FROM THE PHOTO PROVIDED, A SCRATCH ON THE IOL WHERE THE IOL WAS HUNG UP ON THE PLUNGER ROD AND THE TIP OF THE INJECTOR LOOKS CRACKED. THE DOCTOR REMOVED THE LENS AND BACK-UP IOL WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY AND NO VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375654 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EXPLANT OF AN INTRAOCULAR LENS (IOL) DUE TO PATIENT'S REFRACTION POST OP STILL NEEDED IMPROVEMENT AND WAS NOT SATISFIED WITH THE LENS. THE EXPLANTED IOL WAS REPLACED WITH A DIU225 MODEL LENS. THE PATIENT OUTCOME WAS NOT PROVIDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15514975 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WILL BE EXPLANTED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON IOL (DIFFERENT MODEL DIB). THE REASON FOR THE EXPLANT IS THAT WHILE THE DATA SUGGESTED A TORIC WAS NEEDED, A STANDARD MONOFOCAL IS A BETTER FIT. THROUGH FOLLOW-UP WITH THE SALES REP, IT WAS LEARNED THAT THERE WAS NO FAULT OF THE DOCTOR OR THE LENS, IT WAS JUST A CALCULATION ISSUE IN THAT THE MEASUREMENTS WERE ONLY OF THE FRONT OF THE CORNEA, BUT THE BACK OF THE CORNEA WAS ALREADY CORRECTING THE VISION, SO IT RESULTED IN THE WRONG LENS BEING CHOSEN. THE SALES REP DOES NOT KNOW IF THE EXPLANT HAS OCCURRED YET. THROUGH FOLLOW-UP WITH THE LOCATION CONTACT, IT WAS LEARNED THAT IOL WAS EXPLANTED. THE REASON FOR EXPLANT WAS BECAUSE THE PATIENT EXPERIENCED AN UNSPECIFIED VISUAL DISTURBANCE. THE PATIENT WAS NOT HAPPY WITH THE VISION IN THE RIGHT EYE AND WANTED THE LENS TO BE EXPLANTED FOR A NON-TORIC LENS. IT IS UNKNOWN WHY THE TORIC LENS WAS ORIGINALLY CHOSEN FOR THIS PATIENT, BUT IT WAS REPORTED THAT THE PATIENT DID NOT NEED THE TORIC LENS. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AND THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL POST-OPERATIVELY. THE DEVICE WAS D

  Patient problems: Discomfort; Visual Disturbances

  MAUDE report 15325455 ↗
• MalfunctionMar 4, 2022Misassembled; Inaccurate Delivery; Misassembled; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR DEVICE INJECTED THE INTRAOCULAR LENS (IOL) BACKWARDS AND THE SURGEON QUICKLY TURNED TO THE CORRECT DIRECTION. THE LENS REMAINS IMPLANTED IN PATIENT'S OPERATIVE EYE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13676959 ↗
• MalfunctionMar 4, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS HAD A CRACK AT THE HAPTIC-OPTIC JUNCTION WHEN IT WAS PLACED INSIDE PATIENT'S OPERATIVE EYE. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH ANOTHER LENS. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13674841 ↗