TECNIS IOL DIU300 (REF DIU300U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474747623), received between Oct 12, 2023 and Dec 10, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. HOWEVER, THE DOCTOR NOTICED A METALLIC DEBRIS ADHERED TO THE LENS. THE DEBRIS WOULD NOT IRRIGATE SO THE DOCTOR USED AN INSTRUMENT TO PICK IT OFF THE LENS. THE DEBRIS WAS DISCARDED AND WILL NOT BE RETURNED TO JNJ. THE IOL REMAINS IMPLANTED. THERE WAS NO PATIENT HARM AND NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774420 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. POST-OPERATIVE COMPLICATIONS WERE NOTED, INCLUDING HYPEROPIA AT THE ONE-WEEK POST-OPERATIVE MARK (ON (B)(6) 2025), WITH AN UNCORRECTED VISUAL ACUITY OF 20/40+1 AND REPORTS OF BLURRY VISION. MANIFEST REFRACTION WAS MEASURED AT PLANO+1.00X106, ACHIEVING A CORRECTED VISUAL ACUITY OF 20/20, THOUGH IT WAS NOT DEEMED SATISFACTORY. TESTING WITH A +2.0 D CYLINDER TRIAL LENS AT 107 DEGREES PRODUCED AN OVER-REFRACTION OF -1.00+0.75X174, RESULTING IN A VISUAL ACUITY OF 20/20-, WITH A SLOW AND UNCLEAR ENDPOINT. THE INTENDED AXIS FOR THE TORIC LENS WAS 21 DEGREES, BUT THE ACHIEVED AXIS WAS SLIGHTLY MISALIGNED AT 17 DEGREES. DESPITE ACCURATE PRE-OPERATIVE MEASUREMENTS AND CALCULATIONS, THE PATIENT EXPERIENCED SIGNIFICANT POST-OPERATIVE REFRACTIVE ERROR, NECESSITATING CONSIDERATION OF A DIFFERENT MODEL AND DIOPTER, SUCH AS DIU150. THE PATIENT, WHO WAS PREVIOUSLY ABLE TO DRIVE, REPORTED AN INABILITY TO DRIVE AT NIGHT DUE TO ISSUES WITH VISION CLARITY, WHICH HAS BEEN DESCRIBED AS DEBILITATING. THE INTRAOCULAR LENS REMAINS IMPLANTED, WITH THE EXPLANTATION PLANNED BUT NOT YET

  Patient problems: Visual Impairment

  MAUDE report 22152218 ↗
• MalfunctionOct 12, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS OPENED, NOT USED. ADDITIONAL INFORMATION WAS RECEIVED, REPORTING THAT THERE WAS A TORN HAPTIC IN THE INJECTOR. THERE WAS NO PATIENT CONTACT. A NEW LENS WAS USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922509 ↗