TECNIS IOL DXR00V (REF DXR00VU240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474761872), received between Apr 10, 2024 and Jul 3, 2025 — classified as 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED AN ISSUE WITH A MULTIFOCAL INTRAOCULAR LENS (IOL), WHICH HAD BEEN IMPLANTED IN A PATIENT'S RIGHT EYE. THE PATIENT EXPERIENCED DIFFICULTIES WITH MEDIUM TO FAR DISTANCE VISION AND DISCOMFORT WHILE DRIVING AT NIGHT, LEADING TO EXPLANTATION OF THE LENS. NEAR VISION CAN BE DIFFICULT AND PATIENT IS NOT DRIVING AT NIGHT AS HE FEELS UNCOMFORTABLE. THE ISSUE WAS NOTICED DURING POST-OPERATIVE EXAMINATION. THE LENS WAS REPLACED WITH THE SAME LENS MODEL, BUT LOWER DIOPTER (22.5). PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY WAS DOCUMENTED AS 20/20-1, AND POST-OPERATIVE VISUAL ACUITY REMAINED AT 20/20. THERE WERE NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED AND NO DELAY IN PROCEDURE REPORTED. THE CUSTOMER CONFIRMED COMPLIANCE WITH THE DIRECTIONS FOR USE. THE PATIENT HAS NOT PURSUED ADDITIONAL MEDICAL ATTENTION BEYOND STANDARD CARE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22399326 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REPORTED A PLANNED EXPLANT OF AN INTRAOCULAR LENS (IOL) FROM A PATIENT'S LEFT EYE. THE REASON FOR EXPLANT WAS NOT SPECIFIED. THROUGH FOLLOW UPS, IT WAS LEARNED THAT THE LENS WAS EXPLANTED AS SCHEDULED ON (B)(6) 2025 DUE TO BLURRED VISION AT ALL DISTANCES, EVEN WITH CORRECTION. IT WAS CONFIRMED THAT THE PATIENT HAD DEBILITATING CONDITION, MORE DIFFICULTY DRIVING. REPORTEDLY, THE PATIENT HAD PRE-EXISTING ISSUE OF DRY EYE DISEASE. THE REPLACEMENT IOL WAS OF A DIFFERENT MODEL AND LOWER DIOPTER (DRN00V, 23.0D). NO SURGICAL INTERVENTIONS WERE REQUIRED AND NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED TO THE PATIENT. THE PATIENT IS DOING WELL POST-OP AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 21452160 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A PATIENT WHO RECEIVED A MULTIFOCAL SYMFONY INTRAOCULAR LENS (IOL) IS VISUALLY SEEING GREAT WITH DISTANCE VISION BEING 20/20 AND J2 FOR NEARBY. THE PATIENT'S VISION PER-OPERATIVE WAS 20/200 AND POST-OP (AFTER CATARACT SURGERY) WAS 20/20. REPORTEDLY, THE PATIENT FULLY RECOVERED. HOWEVER, THE PATIENT IS EXTREMELY UNHAPPY WITH THE GLARE ASSOCIATED WITH THIS LENS AND CANNOT TOLERATE IT. THAT THE PATIENT IS SO UNHAPPY THAT THE DOCTOR IS DISCUSSING DOING AN REMOVAL & REPLACEMENT (R&R) AND REPLACING THE LENS WITH A NON-JOHNSON & JOHNSON IOL. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT'S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. ON (B)(6) 2024, WHEN THE DOCTOR TRIED TO REMOVE THE LENS DURING A FOLLOW-UP PROCEDURE, THEY ENCOUNTERED SIGNIFICANT SCAR TISSUE AROUND THE LENS, WHICH MADE IT IMPOSSIBLE TO REMOVE. THE CAUSE OF THIS SCAR TISSUE FORMATION IS UNCLEAR AND IT IS UNKNOWN WHY THE PATIENT'S BODY REACTED LIKE THAT. IT WAS CONFIRMED THAT THE PATIENT IS NOT DEBILITATED AND IS FINE. BEFORE THE ATTEMPTED LENS REMOVAL, THE PATIENT¿S UNCORRECTED VISUAL ACUITY WAS 20/20. AFTER THE PROCEDURE, THE PATIENT'S VISION DROPPED TO 20/100 UNCORRECTED. THE

  Patient problems: Visual Disturbances

  MAUDE report 20929030 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DXR00V INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT COULD NOT ADJUST EVEN THOUGH THEY WERE PROVIDED WITH SEVERAL MONTHS TO ADAPT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Halo

  MAUDE report 19536895 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. THE REPLACEMENT LENS WAS NOT ANOTHER JOHNSON AND JOHNSON IOL OF THE SAME MODEL AND DIOPTER. IT WAS STATED THAT THERE WAS NO PATIENT INJURY (SUCH AS CAPSULE TEAR) AND THAT PATIENT WAS EXCELLENT POST-OP. THE EXPLANTED IOL IS NOT RETURNING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19265636 ↗
• MalfunctionApr 10, 2024Break; Difficult to Fold, Unfold or Collapse; Ejection Problem; Break; Difficult to Fold, Unfold or Collapse; Ejection Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED, BROKEN HAPTIC WHEN INSERTING INTO THE PATIENT'S OPERATIVE EYE. TRAILING HAPTIC WAS NOT FOLDED. HE TRIED TO PULL THE PLUNGER BACK AND THAT IS WHEN THE HAPTIC BROKE. MAIN ISSUE IS THAT, TRAILING HAPTIC WAS NOT FOLDED. BACK-UP IOL IMPLANTED, NO PATIENT INJURY, PATIENT IS FINE. NO CAPSULE TEAR, NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081594 ↗