TECNIS IOL DXR00V (REF DXR00VU105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474761605), received between Feb 23, 2023 and Dec 23, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 EXPERIENCED PERSISTENT HALOS AND STARBURSTS AROUND LIGHTS AT NIGHT. THE SYMPTOMS IMPACTED PATIENT¿S DAILY ACTIVITIES SUCH AS NIGHT DRIVING DUE TO GLARE. WAS UNABLE TO PERFORM CERTAIN DAILY ACTIVITIES, SPECIFICALLY DRIVING AT NIGHT DUE TO GLARE. THE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/40 PREOPERATIVELY AND 20/15 POSTOPERATIVELY. THE LENS WAS EXPLANTED DURING A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS (DIB00) OF THE SAME DIOPTER AS THE ORIGINAL LENS. POSTOPERATIVE REFRACTION WITH THE REPLACEMENT LENS WAS 20/30. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR PROCEDURAL DELAYS OCCURRED, AND NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. THE PATIENT IS PERMANENTLY IMPAIRED. DIRECTIONS FOR USE WERE FOLLOWED. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN, AS IT WAS REMOVED IN PIECES USING THE PHACO MACHINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 23875283 ↗
• InjuryFeb 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FOR AN UNSPECIFIED REASON. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS HAS NOT BEEN EXPLANTED YET. IT IS PLANNED TO BE EXPLANTED AT ANOTHER FACILITY. THE REASON FOR THE LENS EXCHANGE IS DUE TO LENS DISLOCATION IN THE PATIENT'S RIGHT EYE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE.

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

  MAUDE report 16433011 ↗