TECNIS IOL DXR00V (REF DXR00VU155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474761704), received between Jan 26, 2023 and Jul 9, 2026 — classified as 2 injuries, 1 malfunction.

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

• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DXR00V, WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AND EXCHANGED FOR A PURESEE LENS DURING A SECONDARY SURGICAL PROCEDURE DUE TO THE PATIENT'S REPORTED QUALITY-OF-VISION CONCERNS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 25770207 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO MECHANICAL COMPLICATION, AND REPLACED WITH (B)(6) IN A SECONDARY PROCEDURE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE PATIENT WAS UNHAPPY WITH VISION AT ALL RANGES. DURING POST-OP EXAMINATION IN FOLLOW UP WITH POST SURGICAL DOCTOR IT WAS STATED THAT IT THE IOL EXCHANGE HAD BEEN SCHEDULED. THERE WAS NO ISSUE WITH LENS, PLUNGER OR CARTRIDGE. THERE WAS NO USE ERROR. ONLY ALCON BSS 15ML WAS USED AS A CARTRIDGE LUBRICANT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052969 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THE SURGEON NOTICED A HOLE IN THE PRE-LOADED DXR00 INTRAOCULAR LENS (IOL) AND DID NOT USE IT. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. THERE WAS NO PATIENT CONTACT, NO INJURY, NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS NO COMPLICATIONS. THE 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 16250972 ↗