TECNIS IOL DXR00V (REF DXR00VU225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474761841), received between May 3, 2024 and Jul 12, 2024 — classified as 2 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 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.

• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS), DUE TO PATIENT COMPLAINING OF GLARE AND HALO, BLURRY VISION. IT WAS LEARNED THAT SYMPTOMS WERE PRESENT IMMEDIATELY AFTER CATARACT SURGERY. INCISION WAS ENLARGED AND SUTURE PLACED AT CONCLUSION OF IOL EXCHANGE. VITRECTOMY WAS NOT NEEDED. EXPLANTED IOL WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL. SYMPTOMS COMPLETELY RESOLVED AFTER IOL EXCHANGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 19736290 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT CANNOT SEE GOOD OUT OF BOTH EYES AND COMPLAINING OF BURNING SENSATION. 1ST PROCEDURE FOR RIGHT EYE (OD) WAS DONE ON (B)(6) 2022. THE PATIENT STATED THAT HER PHYSICIAN GAVE HER RESTASIS FOR THE BURNING IN BOTH EYES. THE PATIENT IS GOING TO SEE HER DOCTOR AGAIN BUT DOES NOT RECALL WHEN. THE PATIENT STATED THAT DURING THE IMPLANT OF OD, SHE HAD NO VISUAL CONCERNS. HOWEVER, AFTER THE LEFT EYE (OS) WAS IMPLANTED, THE VISUAL ISSUES OF BURNING SENSATION LEADING TO BLURRY VISION/CANNOT SEE WELL IN BOTH EYES HAPPENED. THERE WAS NO EYE REDNESS. THE PATIENT WENT TO HER IMPLANT DOCTOR WHO TOLD HER THAT HER NUMBERS WERE ALL GOOD. BUT HER DOCTOR GAVE HER REFRESH AND RESTASIS EYE DROPS, WHICH HELP WITH THE "EYE BURNING" THAT LED TO NOT SEEING CLEARLY. THE PATIENT REPORTED THAT SHE WAS STILL KIND OF ABLE TO READ, WATCH TV AND DRIVE BUT HAS TO BE WITH EYEGLASSES. THE PATIENT GOT SCARED OF DRIVING SINCE SHE HAD BEEN TO TWO ACCIDENTS ALREADY. FOR 2 1/2 WEEKS NOW, THE PATIENT HAS NOT BEEN DRIVING ANYMORE. THE PATIENT STATED THAT SHE IS GOING TO SEE ANOTHER DOCTOR SOON FOR 2ND OPINION. IN FOLLOW UP WITH THE DOCTOR, IT WAS STATED THAT THE PATIENT HAD YTTRIUM ALUMINUM GARNE

  Patient problems: Blurred Vision; Dry Eye(s); Eye Irritation

  MAUDE report 19236042 ↗