TECNIS IOL DXR00V (REF DXR00VU230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474761858), received between Mar 8, 2024 and Mar 17, 2025 — classified as 4 injuries.

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.

• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DXR00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT REPORTS CONCENTRIC CIRCLES AND STARBURSTS ARE SEEN WITH BRIGHT LIGHTS AND ALL LIGHTS BLUR TOGETHER AT NIGHT TIME. SYMPTOMS DO NOT OCCUR DURING THE DAY AND THE PATIENT CAN'T MAKE PLANS AFTER 4PM DUE TO VISUAL ISSUES. PILOCAR WAS PRESCRIBED AFTER THE LENSES WERE IMPLANTED AND PATIENT TAKES RESTASIS 2X A DAY FOR DRY EYE WHICH IS WORKING; PATIENT HAD DRY EYES PRIOR TO THE IOL IMPLANTS. SHE ALSO REPORTS WHEN HER EYES MOVE FROM SIDE TO SIDE IT FEELS LIKE THE LENS IS MOVING. PATIENT IS GETTING 2ND OPINION IN MAY. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers; Halo

  MAUDE report 21627170 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THE PATIENT DID NOT EXPERIENCE THE EXPECTED QUALITY OF VISION, AND ADDITIONAL INFORMATION SUGGESTS THAT THEY HAD POSTOPERATIVE DYSPHOTOPSIA, WHICH AFFECTED THEIR DAILY ACTIVITIES. THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED IN A SECONDARY SURGICAL PROCEDURE WITH A NON J&J LENS. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 20051849 ↗
• InjuryJul 11, 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/REMOVED BECAUSE BAG ASSEMBLY WAS NOT ABLE TO SUPPORT THE IOL. THE IOL WAS NOT SAVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 19726739 ↗
• InjuryMar 8, 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 A PATIENT¿S OPERATIVE EYE. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 18867787 ↗