TECNIS IOL DXR00V (REF DXR00VU245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474761889), received between May 5, 2023 and Mar 26, 2026 — 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 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DXR00V, WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. POSTOPERATIVELY, THE PATIENT REPORTED DISSATISFACTION WITH VISUAL QUALITY, INCLUDING STARBURSTS WHEN DRIVING OR VIEWING LIGHTS, AS WELL AS HALOS, GLARE, AND OTHER VISUAL DISTURBANCES. AN IOL EXPLANT WAS INITIALLY SCHEDULED FOR (B)(6) 2026 AND SUBSEQUENTLY RESCHEDULED TO (B)(6) 2026. IT WAS CONFIRMED THAT THE EXPLANT PROCEDURE WAS COMPLETED, AND A PRELOADED MONOFOCAL IOL (MODEL DCB00, +24.5 DIOPTER) WAS IMPLANTED AS THE REPLACEMENT LENS. THE PRE-OPERATIVE REFRACTION ASSOCIATED WITH THE ORIGINALLY IMPLANTED MULTIFOCAL IOL WAS +0.50 DIOPTERS, AND THE POST-OPERATIVE REFRACTION WAS ¿0.50 DIOPTERS, WITH AN INTENDED REFRACTIVE TARGET OF ¿0.30 DIOPTERS. NO YAG CAPSULOTOMY, UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED DURING THE EXPLANT PROCEDURE. THE PATIENT¿S POST-EXPLANT CLINICAL OUTCOME IS UNKNOWN AT THIS TIME. A FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR (B)(6) 2026. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 24706779 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED LENS WAS EXPLANTED BECAUSE THE PATIENT NEVER FELT THAT THEIR DISTANCE VISUAL ACUITY WAS CLEAR AND SEEMED OUT OF FOCUS. THE PATIENT ALSO EXPERIENCED DIFFICULTY DRIVING AT NIGHT DUE TO GLARE AND HALOS. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH AN UNKNOWN LENS. THERE WERE NO INJURIES AND NO MEDICAL INTERVENTION WAS REQUIRED. THE BEST-CORRECTED VISUAL ACUITY (BCVA) IMPROVED FROM 20/30 PRE-OPERATIVELY TO 20/20 POST-OPERATIVELY. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 21541462 ↗
• InjuryApr 9, 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). DUE TO REPORTS OF IOL MECHANICAL COMPLICATIONS, THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-J&J LENS. IOL MECHANICAL COMPLICATION WAS CLARIFIED AS PATIENT REPORTING BLURRY VISION WHEN LOOKING FAR AWAY. PATIENT CONTINUED TO REPORT BLURRY VISION DURING (B)(6) 2024 FOLLOW-UP APPOINTMENT. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION DURING IOL EXCHANGE PROCEDURE. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 19076731 ↗
• InjuryMay 5, 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 EXPLANTED FROM THE PATIENT'S RIGHT EYE AS THE PATIENT COULD NOT TOLERATE GLARE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. SUSPECT LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. NO PATIENT POST-OP INJURY REPORTED. PATIENT IS WELL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16876984 ↗