TECNIS IOL DIU225 (REF DIU225U245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474747227), received between Aug 30, 2022 and Jan 21, 2026 — classified as 2 injuries, 2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT AFTER THE NON-PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT HAS BEEN EXPERIENCING SEVERE POSITIVE DYSPHOTOPSIAS, DESCRIBED AS VISUAL DISTURBANCES RESEMBLING FIREWORKS, CHRISTMAS LIGHTS, FERRIS WHEELS, AND MUSHROOM LIGHTS, PARTICULARLY NOTICEABLE AT NIGHT AND AROUND LIGHT SOURCES, PUDDLES, OR SHINY OBJECTS. GLARE AND BLURRY VISION WERE ALSO REPORTED. THESE SYMPTOMS HAVE SIGNIFICANTLY IMPACTED DAILY ACTIVITIES, INCLUDING DRIVING AND NIGHTTIME OUTINGS. THE PATIENT REPORTED BEING UNABLE TO DRIVE AT NIGHT DUE TO POOR VISION. FOLLOW-UP EXAMINATIONS HAVE INDICATED NO ISSUES, AND ATTEMPTS TO ALLEVIATE THE SYMPTOMS USING BLUE LIGHT GLASSES HAVE NOT RESULTED IN IMPROVEMENT. THE PATIENT WAS INFORMED BY THE DOCTOR THAT TIME IS NEEDED FOR NEUROADAPTATION, HOWEVER THE PATIENT DOES NOT SEE ANY VISUAL IMPROVEMENTS AS TIME PASSES. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE LEFT EYE EVENT. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE PATIENT'S RIGHT EYE EVENT.

  Patient problems: Blurred Vision; Discomfort; Flashers; Halo; Visual Disturbances

  MAUDE report 24139752 ↗
• MalfunctionNov 28, 2023Break; Break

  IT WAS REPORTED THE DIU225 MODEL INTRAOCULAR LENS (IOL) WAS DAMAGED INSIDE THE BOX BUT THE BOX WAS NOT CRUSHED; DAMAGE OCCURRED IN TRANSIT. THERE WAS NO PATIENT CONTACT AS THE DEVICE NEVER MADE IT INTO THE OPERATING ROOM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223486 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. THE IOL WAS EXPLANTED BECAUSE THE PATIENT EXPERIENCED SYMPTOMATIC ANISOMETROPIA DESCRIBED AS PERIPHERAL VISION BLURRINESS AND HALO. THE DATE OF ONSET WAS REPORTED AS (B)(6) OF 2023. REPORTEDLY, THE SYMPTOMS SIGNIFICANTLY INTERFERED WITH NORMAL DAILY ACTIVITIES LIKE READING AND DRIVING. THE REPLACEMENT LENS IS THE SAME MODEL BUT DIFFERENT DIOPTER. MODEL DIU225 21.0 DIOPTER. AN INCISION ENLARGEMENT WAS REQUIRED. THERE WAS NO PATIENT INJURY. NO MEDICATION OUTSIDE THE NORMAL STANDARD OF CARE WAS PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 17098520 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED VIA PHONE THAT DURING HANDLING, THE HAPTIC OF A PRELOADED LENS WAS BENT IN THE LOADER. THERE WAS NO PATIENT CONTACT. CUSTOMER USED THE BACK-UP LENS TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325077 ↗