AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652415576), received between Mar 11, 2021 and Jul 7, 2022 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HALOS AND DIFFICULTY IN DRIVING IN NIGHT. THE PATIENT HAD YAG (YTTRIUM ALUMINUM GARNET) PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT HAS GOT THE GLASSES FOR NIGHT DRIVING AND HAS ALSO TRIED UNSPECIFIED EYE DROPS BY SURGEON TO HELP WITH GLARE BUT NOTHING IS HELPING. THE PATIENT ALSO STATES IT'S ONLY WITH NIGHT DRIVING, HER HUSBAND DOES THE DRIVING BECAUSE GLARE IS TOO MUCH FOR HER. SURGEON STATES SHE'S NOT ABLE TO HAVE EXPLANT DUE TO HER BEING S/P YAG. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances

  MAUDE report 14947079 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT APPROXIMATELY ONE MONTH AFTER INITIAL IMPLANTATION, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER MODEL LENS DUE TO INADEQUATE NEAR VISION FOR FINE JEWELRY. IT WORKS WITH NEAR GLASSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 13151209 ↗
• InjuryJun 3, 2021Adverse 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 SEVERE HALOS DAY AND NIGHT. THE IOL WAS EXPLANTED 15 MONTHS AFTER THE INITIAL PROCEDURE AND REPLACED WITH A MONOFOCAL LENS FOR CLINICAL REASON OF SEVERE DYSPHOTOPSIAS AND LACK OF NEUROADAPTATION TO DIFFRACTIVE IOL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 11928943 ↗
• InjuryMay 25, 2021Adverse 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 HALOS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR CLINICAL REASON OF GLARE WHILE DRIVING NIGHT AND DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11878520 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED A PATIENT EXPERIENCING HALOS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE PATIENT WAS VERY HAPPY DURING THE FIRST FIVE WEEKS OF HAVING THE IMPLANT. IT WAS ONLY AFTER BEING DILATED ON THE 5TH WEEK THAT THE PATIENT BEGAN REPORTING HALOS AND BLURRY VISION. POST OP VISION WAS 20/20 AND PATIENT HAPPY POST OPERATIVELY (PRIOR TO DILATION AT FOLLOW UP). THE IOL WAS EXCHANGED FOR ANOTHER MODEL 13 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE PATIENT ALSO EXPERIENCED HEADACHES AND UNABLE TO READ PRIOR TO THE LENS EXCHANGE.

  Patient problems: Blurred Vision; Halo; Headache

  MAUDE report 11465791 ↗