TECNIS IOL DIU300 (REF DIU300U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474747753), received between Feb 17, 2023 and Apr 29, 2026 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A MYOPIC SURPRISE FOLLOWING IMPLANTATION OF A SINGLE-PIECE PRELOADED TORIC INTRAOCULAR LENS (IOL) IN THE DOMINANT EYE. THE PHYSICIAN STATED THAT A NON JOHNSON & JOHNSON IOL HAD BEEN IMPLANTED IN THE PATIENT¿S FIRST EYE SEVERAL YEARS EARLIER. POSTOPERATIVELY, THE PATIENT EXPRESSED DISSATISFACTION WITH THE SURGICAL OUTCOME. HOWEVER, THE PATIENT REPORTEDLY UNDERSTOOD THAT THE EVENT WAS NOT RELATED TO THE LENS TYPE BUT RATHER TO INDIVIDUAL HEALING RESPONSE. THE PHYSICIAN SCHEDULED AN IOL EXCHANGE TO ADDRESS THE ISSUE. ADDITIONAL INFORMATION INDICATED THAT THE PRODUCT WAS RETURNED AND INVESTIGATED INDICATING THAT THE EXPLANT WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25034402 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. WHEN THE DOCTOR IMPLANTED THE LENS IT CAME OUT DEFECTIVE, TWISTED WHICH REQUIRED REMOVAL. THE PROCEDURE WAS COMPLETED USING A BACKUP LENS OF THE SAME MODEL AND DIOPTER, WITH NO ADDITIONAL COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659500 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRE-LOADED DIU300 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS HIS BLURRY VISION FOR DISTANCE WITHOUT GLASSES SIGNIFICANTLY INTERFERES WITH HIS DAILY ACTIVITIES, HE IS VISUALLY FASTIDIOUS, AND IS VERY UNHAPPY WITH DISTANCE VISION. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION DURING THE INITIAL PROCEDURE. PRE-OPERATIVE UNCORRECTED BEST CORRECTED VISUAL ACUITY (BCVA) WAS REPORTED AS 20/30 AND GLARE 20/50 AND POST-OPERATIVE UNCORRECTED VISUAL ACUITY (UCVA) WAS 20/70 AND BCVA WAS 20/25+2. AN IOL EXPLANT PROCEDURE IS SCHEDULED FOR (B)(6) 2025 HOWEVER, THERE IS NO CONFIRMATION THAT THE IOL EXPLANT HAS OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 21330570 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THE IOL WAS REMOVED AND REPLACED DUE TO COMPLAINTS OF HEALED HYPEROPIC, REFRACTIVE SURPRISE. THERE WAS NO DELAY IN PROCEDURE, NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF STANDARD CARE WAS PRESCRIBED, NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. REPLACEMENT LENS INFORMATION WAS NOT PROVIDED. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED.

  Patient problems: Visual Impairment

  MAUDE report 16401120 ↗