TECNIS IOL DIU150 (REF DIU150U255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474746657), received between Jan 26, 2023 and Dec 10, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED BY THE CUSTOMER THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIU150 WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). INCORRECT DIOPTER SELECTED, RESULTING IN POOR DISTANCE VISION AND PATIENT DISSATISFACTION. LOCATION OF IMPLANT FOR THE OD AT 20 DEGREES. LENS WAS LATER EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. THE PATIENT OUTCOME IS UNKNOWN/NOT PROVIDED. THE EXPLANTED LENS WAS NOT KEPT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 23765064 ↗
• InjuryDec 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRE-LOADED DIU150 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE BEEN IMPLANTED IN THE PATIENT'S EYE. THE IOL WAS EXPLANTED AND REPLACED WITH A DIB00 23.0 DIOPTER IOL THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT VISUAL ACUITY POST-LENS EXCHANGE WAS REPORTED AS 20/40. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 20873482 ↗
• MalfunctionOct 18, 2024Crack; Crack

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) CARTRIDGE BROKE DURING LENS INJECTION. THE SURGEON USED BACKUP LENSES AND THE CARTRIDGE TIP CAME INTO CONTACT WITH THE PATIENT. NO INJURIES OR MEDICAL INTERVENTIONS OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482383 ↗
• MalfunctionJan 26, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE SURGEON WAS ABLE TO MANIPULATE THE PRELOADED INTRAOCULAR LENS (IOL) HAPTICS WITH SURGICAL INSTRUMENTS TO ENSURE THE LENS WAS SAFELY IMPLANTED IN THE RIGHT EYE. THERE WAS NO DAMAGE OR ISSUE WITH THE LENS OR HAPTIC DURING INSERTION. THERE WAS NO ISSUE WITH THE LENS OR PATIENT AFTER THE LENS WAS IMPLANTED. THE PATIENT HAS NO COMPLICATIONS POST-OPERATIVELY AND HAS GOOD OUTCOMES. THERE ARE NO PLANNED INTERVENTIONS. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247671 ↗
• MalfunctionJan 26, 2023Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) TRAILING HAPTIC GOT STUCK IN THE CARTRIDGE, SCRUNCHING IT, WHILE BEING INJECTED IN THE RIGHT EYE. THE LENS WAS FULLY INSERTED AND THEN REMOVED AND REPLACED IN THE SAME PROCEDURE. NO ADDITIONAL SURGICAL MANEUVERS WERE REQUIRED. WHEN THE LENS WAS REMOVED THERE WAS MINOR INJURY TO THE IRIS, HOWEVER NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL AND DIOPTER). THE INCISION WAS ENLARGED. THE LENS IS NOT AVAILABLE FOR RETURN AND EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury

  MAUDE report 16247601 ↗
• MalfunctionJan 26, 2023Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) TRAILING HAPTIC GOT STUCK IN THE CARTRIDGE, SCRUNCHING IT, WHILE BEING INJECTED IN THE RIGHT EYE. THE LENS WAS PARTIALLY INSERTED AND THEN REMOVED. NO ADDITIONAL SURGICAL MANEUVERS WERE REQUIRED. A BACK-UP LENS WAS USED (SAME MODEL AND DIOPTER). THE LENS IS NOT AVAILABLE FOR RETURN AND EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247557 ↗