TECNIS IOL DXR00V (REF DXR00VU160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474761711), received between Jun 12, 2023 and Jun 4, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS SCHEDULED FOR EXPLANTATION DUE TO INTOLERANCE TO DYSPHOTOPSIA. ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS SUBSEQUENTLY EXPLANTED FROM THE PATIENT'S LEFT EYE ON (B)(6) 2026 AND REPLACED WITH A PURESEE LENS OF THE SAME DIOPTER POWER AS THE ORIGINAL LENS. A MINOR INCISION ENLARGEMENT WAS PERFORMED TO FACILITATE THE PROCEDURE; HOWEVER, NO SUTURES, VITRECTOMY, OR OTHER SURGICAL INTERVENTIONS WERE REQUIRED. NO PATIENT INJURY, INCLUDING CAPSULAR TEAR, WAS REPORTED. THE PATIENT OUTCOME WAS REPORTED AS NORMAL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 25402627 ↗
• InjuryFeb 11, 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). DUE TO COMPLAINTS OF REFRACTIVE MISS AND PARTLY BECAUSE THE PATIENT WANTED MORE NEAR VISION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT150 16.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS AND VISUAL ACUITY POST-LENS EXCHANGE WAS REPORTED AS EXCELLENT, 20/30 AND J1. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Visual Impairment

  MAUDE report 21358613 ↗
• InjuryJun 12, 2023Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OPERATIVE EYE. IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO INCORRECT POWER AND THE EXPLANTED IOL WAS REPLACED WITH A SYMFONY OPTIBLUE IOL, DIOPTER SIZE IS UNKNOWN. PATIENT STATUS POST-LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114386 ↗