TECNIS IOL DIU300 (REF DIU300U130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474747586), received between Jun 21, 2022 and Apr 21, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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.

• MalfunctionApr 21, 2026Material Fragmentation; Device Difficult to Setup or Prepare; Ejection Problem

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL). UPON INSERTING THE CARTRIDGE INTO THE CLEAR CORNEAL INCISION (CCI) WHILE ADVANCING THE LENS, THE FIRST PART OF THE IOL ENTERED THE CCI THE DOCTOR FELT RESISTANCE. THE DOCTOR STOPPED AND REALIZED THE TORIC IOL WAS CRACKED IN HALF. THE FIRST PART OF THE IOL WAS ALREADY IN THE ANTERIOR CHAMBER (AC) WHILE THE SECOND HALF OF THE IOL WAS IN THE INJECTOR NOZZLE. THE INSERTER WAS PULLED OUT OF THE CORNEAL INCISION, AND THE FIRST HALF OF THE IOL WAS RETRIEVED FROM THE ANTERIOR CHAMBER. AS THE DAMAGED IOL OPENED UP IN THE ANTERIOR CHAMBER IT LIGHTLY NICKED THE PATIENTS' ENDOTHELIUM, LEAVING A SMALL 2-MILLIMETER SCRATCH. THE BROKEN OPTIC AND SINGLE HAPTIC WERE REMOVED. A BACKUP IOL WAS IMPLANTED SUCCESSFULLY WITHOUT ADDITIONAL COMPLICATIONS. THE PATIENT IS DOING WELL. A PHOTOGRAPH OF THE DAMAGED LENS WAS PROVIDED. JOHNSON AND JOHNSON REQUESTED THE RETURN OF THE PRODUCT AND THE CUSTOMER BELIEVES THEY HAVE ALREADY RETURNED IT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Corneal Abrasion

  MAUDE report 24948574 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF TORIC UNCORRECTED ASTIGMATISM, POST-SURGERY. BLURRED VISION WITH OCULAR IMBALANCE FROM UNCORRECTED ASTIGMATISM. FIRST OBSERVED DURING POST-OPERATIVE EXAMINATION. DIPLOPIA/POOR STEREOVISION. PREOP VISUAL ACUITY: 20/30-1. POST OP VISUAL ACUITY 20/30. 1 MONTH DELAY IN PROCEDURE. ADDITIONAL ATR CYL CORRECTION NEEDED. LENS EXCHANGE FOR HIGHER POWER TORIC REQUIRED. DIU300 IOL WAS REPLACED WITH A DIU375 13.0 DIOPTER IOL. THERE WERE NO COMPLICATIONS, NO SUTURE(S), NO INJURY, AND NO VITRECTOMY. PATIENT OUTCOME POST LENS EXCHANGE IS UNKNOWN. DIU300 IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16344254 ↗
• MalfunctionJun 21, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT SCRATCH WAS NOTED ON THE PRELOADED INTRAOCULAR LENS (IOL) NEAR HAPTICS AFTER THE LENS WAS INSERTED INTO PATIENT'S LEFT EYE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14763616 ↗