TECNIS IOL DIU300 (REF DIU300U245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474747814), received between Jan 18, 2024 and Oct 11, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS(IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE, AND PATIENT WAS NOT HAPPY WITH THE VISION DUE TO NOT GETTING DISTANCE AND WANTED TO GO WITH A DIFFERENT LENS. THE ISSUE WAS IDENTIFIED DURING POST-OP WITH THE DATE OF FIRST SYMPTOMS BEING ON (B)(6) 2024. THERE WAS NO PATIENT INJURY AND NO VISUAL ISSUES REPORTED. FROM ADDITIONAL INFORMATION, IT WAS LEARNT THAT THE LENS WAS REMOVED AND REPLACED WITH DIB00 +21.5 DIOPTER INTRAOCULAR LENS. THERE WAS NO CAPSULAR TEAR. THE PATIENT IS DOING GREAT, AND HAPPY WITH THE RESULTS POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 20432800 ↗
• MalfunctionJun 3, 2024Material Fragmentation; Material Fragmentation

  IT IS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS(IOL) TRAILING HAPTIC TORE OFF DURING THE INSERTION OF THE IOL. ADDITIONAL INFORMATION SUGGESTS THAT IT WAS NOTICED DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER J&J IOL WITH THE SAME MODEL AND DIOPTER. THE LENS WAS PARTIALLY OR FULLY INSERTED IS UNKNOWN. NO INJURY OR MEDICAL INTERVENTION IS REQUIRED. THE PATIENT STATUS IS DOING. THE PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454642 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S OPERATIVE EYE DUE TO BLURRED VISION. THE ISSUE WAS NOTED DURING POST-OPERATIVE EXAMINATION. THE INCISION WAS ENLARGED; HOWEVER, NO VITRECTOMY OR SUTURES REQUIRED AND NO DELAY IN PROCEDURE REPORTED. THE PATIENT IS DOING WELL AFTER THE IOL EXCHANGE AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 18539989 ↗