TECNIS IOL DXR00V (REF DXR00VU190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474761773), received between Jun 12, 2023 and Aug 25, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A LENS WAS EXPLANTED DUE TO THE PATIENT BEING UNABLE TO FOCUS POSTOPERATIVELY, EXPERIENCING HALOS AND HAZE. THE PATIENT WAS UNABLE TO PERFORM ONE OR MORE DAILY ACTIVITIES POST-SURGERY, AND SECONDARY SURGICAL INTERVENTION WAS REQUIRED. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH (B)(6). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 22891817 ↗
• MalfunctionOct 22, 2024Crack; Crack

  IT WAS INITIALLY REPORTED THAT THE CARTRIDGE SPLIT, COULD NO DEPLOY THE INTRAOCULAR LENS (IOL). THE EXTENT OF PATIENT CONTACT WAS UNKNOWN. THROUGH A FOLLOW UP, IT WAS LEARNED THAT THE TIP OF THE CARTRIDGE WAS DAMAGED. IT WAS INDICATED THAT THERE WAS PATIENT CONTACT, ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE PATIENT'S RIGHT EYE. THE PROCEDURE COMPLETED SUCCESSFULLY USING A BACKUP LENS. NO MEDICAL/SURGICAL INTERVENTION OR ADDITIONAL MANEUVERS REQUIRED AND THERE WAS NO PATIENT INJURY REPORTED. IT WAS NOTED THAT THE DEVICE WILL NOT BE RETURNED, IT HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20511271 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AFTER THE PRELOADED EXTENDED DEPTH OF FOCUS INTRAOCULAR LENSES (IOLS) WERE IMPLANTED INTO THE RIGHT AND LEFT EYE, THE PATIENT HAS BEEN EXPERIENCING HALOS, STARBURSTS, AND GLARE. THOUGH FOLLOW-UP, IT WAS LEARNED THAT SOON AFTER THE LENSES WERE IMPLANTED, THE PATIENT BEGAN TO EXPERIENCE SEVERE STARBURST, HUGE HALOS, GLARE, AND SPIDERWEBS AT NIGHT AND IS NO LONGER ABLE TO DRIVE AT NIGHT DUE TO THESE ISSUES. THE PATIENT IS ABLE TO SEE GREAT DURING THE DAY. THE PATIENT REPORTED HAVING "A SORT OF MENTAL BREAKDOWN" BECAUSE OF THE VISUAL ISSUES. THE PATIENT IS GOING TO GET A SECOND OPINION WITH ANOTHER SURGEON TO SEE IF THE LENSES CAN BE EXCHANGED FOR MONOFOCAL LENSES. NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN PERFORMED. THERE ARE NO PLANNED INTERVENTIONS. THE LENSES REMAIN IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE EVENT FOR THE RIGHT EYE. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE EVENT FOR THE LEFT EYE.

  Patient problems: Distress; Flashers; Halo; Visual Disturbances

  MAUDE report 19244267 ↗
• MalfunctionApr 1, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD HAPTIC DAMAGE. FROM ADDITIONAL INFORMATION IT WAS LEARNED THAT THE BENT HAPTIC WAS NOTICED AFTER LOADING. THE ISSUE WAS IDENTIFIED DURING HANDLING AND PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH THE BACK UP LENS WITH THE SAME MODEL AND SAME DIOPTER. THERE WAS NO USE ERROR. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015358 ↗
• MalfunctionNov 20, 2023Break; Break

  IT WAS REPORTED WHEN THE DOCTOR WAS ABOUT TO INSERT THE DXR00V MODEL INTRAOCULAR LENS (IOL) HE NOTICED A DEFECT; CARTRIDGE TIP HAD CONTACT WITH THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). BACK-UP LENS WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO MEDICAL OR SURGICAL INTERVENTION. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS DOING FINE. SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18179186 ↗
• MalfunctionJun 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED AFTER IMPLANTATION, THE DOCTOR NOTICED A HAPTIC WAS MISSING ON THE DXR00V MODEL INTRAOCULAR LENS (IOL). THE IOL WAS REMOVED FROM THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) AND THE SAME PROCEDURE WAS COMPLETED USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE, DXR00V 19.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION WAS REQUIRED, NO SUTURES, AND NO VITRECTOMY. PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113606 ↗