AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652429511), received between May 23, 2023 and Dec 12, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Opacification” (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 16, 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.

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

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS 1 MONTH FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION.

  Patient problems: Blurred Vision

  MAUDE report 20914187 ↗
• InjuryMay 23, 2023Material Opacification; Material Opacification

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPRESSED SOME CONCERNS AND ISSUES ABOUT THE LENS THAT WAS IMPLANTED. THE PATIENT STATED MUST USE READERS, SINCE THE PATIENT CAN'T SEE UP CLOSE VERY GOOD, IT WAS LIKE THE LENS HAD A CLOUD OVER IT. THE PATIENT COULD SEE BETTER FROM THE LEFT EYE WITH A CONTACT LENS. IT SEEMS TO DO ALL OF THE WORK NOW. AT NIGHT, THERE IS A "HALO" OR "STARBURST" OF LIGHT WITH THE MULTI-FOCAL LENS TO WHERE THE PATIENT COULD NOT SEE OUT OF IT. THE PATIENT WAS CONSTANTLY USING EYE DROPS IN THE RIGHT EYE LIKE NEVER BEFORE, BECAUSE IT ALWAYS FEELS DRY AND IRRITATED, PRETTY MUCH EVERY DAY. SOMETIMES, IT'S LIKE THERE IS SOMETHING IN THE EYE, AS WHEN A CONTRACT LENS GETS CURLED UP IN THE TOP OF THE EYE BY ACCIDENT. IT IS VERY UNCOMFORTABLE MOST DAYS. THE PATIENT RECENTLY HAD THE YAG SURGERY ON RIGHT EYE REALLY DIDN'T NOTICE A DIFFERENCE AND STILL HAVE TO WEAR READERS TO SEE CLOSE UP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Dry Eye(s); Halo; Irritability; Visual Disturbances

  MAUDE report 16982149 ↗