TECNIS IOL DXR00V (REF DXR00VU185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474761766), received between Apr 26, 2023 and Oct 24, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2024Adverse 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 EXPLANTED BECAUSE THE PATIENT COMPLAINED OF INTOLERABLE HALOS AND GLARE AT NIGHT AND IS UNABLE TO DRIVE IN THE DARK. THE PATIENT¿S STATUS WAS REPORTED AS TEMPORARILY IMPAIRED. BOTH THEIR PRE AND POST-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) IS 20/20. THE INCISION WAS ENLARGED. SUTURES WERE USED PROPHYLACTICALLY, AND MYOPIC DROPS WERE PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20529944 ↗
• InjuryJun 19, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S EYE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THERE WAS SOME ISSUE WITH THE HAPTIC AND THE LENS WAS EXPLANTED. REPORTEDLY THE LENS WAS STUCK IN INJECTOR DURING IMPLANTATION. THE LENS WAS FULLY INSERTED, REMOVED AND REPLACED WITH A SAME MODEL AND SAME DIOPTER LENS. THERE WAS NO USE ERROR. THERE WAS NO PATIENT INJURY. SUTURES WERE USED. THE PATIENT'S VISION HAS IMPROVED. THERE WERE NO DAILY ACTIVITIES AFFECTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566906 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DXR00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO PATIENT COMPLAINTS OF DISSATISFACTION WITH NEAR VISION. THE EXPLANTED IOL WAS REPLACED WITH DFR00V 18.5 DIOPTER IOL. THE DECISION TO EXPLANT THE IOL WAS NOT DUE TO A PRODUCT QUALITY ISSUE. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS 100% SATISFIED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 18857072 ↗
• MalfunctionSep 26, 2023Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) GOT STUCK AT THE INCISION. PER THE TECHNICIAN, THE IOL WAS DEFECTIVE PRIOR TO IMPLANTATION. ANOTHER IOL OF THE SAME MODEL AND DIOPTER WERE USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17815364 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THE IMPLANTING DOCTOR REPORTED THE PATIENT WAS NOT COMPLETELY HAPPY WITH HER VISION AFTER SURGERY OVER A FOUR MONTH PERIOD. THERE WERE NO SURGICAL COMPLICATIONS. THE CLINIC WAS TRYING TO ADDRESS THE PATIENT¿S PRE-EXISTING SEVERE DRY EYE AND CORNEAL ISSUES. THE PATIENT HAD A PRIOR LASIK SURGERY AND HAS HAD EPISODES OF DRY EYE OVER THE YEARS. THE PATIENT SOUGHT A SECOND OPINION FROM SEVERAL LOCAL SURGEONS. A LOCAL SURGEON EXPLANTED THE JNJ IOL DUE TO THE PATIENT EXPERIENCING BLURRY VISION AND HALOS. REPORTEDLY, THE SYMPTOMS WERE EXPERIENCED SOON AFTER THE IMPLANT. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY OR SUTURES. THE PATIENT IS DOING WELL. THE EXPLANTED IOL WILL NOT BE RETURNED TO JNJ AS IT WAS DISCARDED BY THE DOCTOR'S OFFICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Halo

  MAUDE report 16820709 ↗