TECNIS IOL DXR00V (REF DXR00VU215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474761827), received between Nov 9, 2023 and Feb 3, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS), MODEL DXR00V, THE PATIENT EXPERIENCED SHADOWED VISION AND GLARE INTOLERANCE IN THE RIGHT EYE. LENS WAS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, SURGICAL DELAYS, OR MEDICATIONS OUTSIDE OF STANDARD CARE WERE REQUIRED. THE PATIENT¿S BEST CORRECTED VISUAL ACUITY REMAINED 20/20 BOTH BEFORE AND AFTER THE PROCEDURES. THE PATIENT REPORTED TEMPORARY VISUAL IMPAIRMENT, INCLUDING AN INABILITY TO DRIVE AT NIGHT AFTER THE PRIMARY SURGERY. REPLACEMENT LENS IMPLANTED IN RIGHT EYE WAS NON¿JOHNSON & JOHNSON PRODUCTS. POST OPERATIVE REFRACTION FOR THE REPLACEMENT LENS HAS NOT YET BEEN MEASURED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 24254826 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED EXTENDED RANGE OF VISION INTRAOCULAR LENS (IOL) WAS SCHEDULED TO BE EXCHANGED FOR AN ODYSSEY IOL IN THE RIGHT EYE, DUE TO THE PATIENT WANTING MORE NEAR VISION. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT THE LENS WAS EXPLANTED, AS PLANNED. THE SURGEON REPORTED THAT THE SURGERY WENT WELL. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 23995526 ↗
• InjuryJun 4, 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 OPERATIVE EYE. DUE TO COMPLAINTS OF HALOS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE; REPLACEMENT IOL INFORMATION WAS NOT PROVIDED. THERE WAS NO SUTURES AND NO VITRECTOMY HOWEVER, THE INCISION WAS ENLARGED. PATIENT VISUAL ACUITY PRE-OPERATIVE WAS 20/40 AND POST-OPERATIVE WAS 20/20. PATIENT PROGNOSIS POST-LENS EXCHANGE WAS REPORTED AS DOING WELL AFTER IOL EXCHANGE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 19459141 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DXR00V WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. THE REASON FOR EXPLANT WAS NOT SPECIFIED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18432719 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN THE RIGHT AND LEFT EYE, THE PATIENT COULD NOT TOLERATE THE GLARE AND HALO AT NIGHT IN BOTH EYES. THE PATIENT'S SYMPTOMS STARTED SHORTLY AFTER THE INITIAL IMPLANT SURGERY FOR BOTH EYES, BUT SPECIFIC DATES ARE UNKNOWN.THE SURGEON MADE EVERY POSSIBLE ADJUSTMENT WITH GLASSES, DROPS, AND YTTRIUM ALUMINUM GARNET (YAG) LASER TO IMPROVE THE PATIENT¿S CONDITION. THE EYE DROPS GIVEN TO THE PATIENT WERE OUTSIDE OF THE STANDARD OF CARE, HOWEVER, IT IS UNKNOWN WHAT DROPS WERE PROVIDED. THE DATE(S) OF THE YAG PROCEDURE AND WHICH EYE IT WAS PERFORMED ON IS UNKNOWN. THE SURGEON SENT THE PATIENT FOR A SECOND OPINION AND BOTH IOLS WERE EXCHANGED BY A DIFFERENT SURGEON FOR NON-JOHNSON AND JOHNSON MONOFOCAL IOLS. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS FULLY RECOVERED. THE LENSES WERE DISCARDED. ADDITIONAL INFORMATION WAS RECEIVED FROM A LETTER FROM THE PATIENT, REPORTING THAT THE MULTIFOCAL LENSES DID NOT YIELD THE EXPECTED RESULTS AND THE PATIENT EXPERIENCED SEVERE AND SIGNIFICANT HALOS AROUND LIGHT SOURCES AND DISCOMFORT, PARTICULARLY WH

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18406164 ↗
• InjuryNov 9, 2023Adverse 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 OPERATIVE EYE. THE DXR00V IOL WAS REPLACED WITH A DIB00 IOL, DIOPTER SIZE UNKNOWN, IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF HALOS AND THE PATIENT COULD NOT READ WITH THE LENS. THERE WERE NO ISSUES WITH THE SURGERY. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS DOING WELL ON POST OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18108218 ↗