AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652418638), received between Apr 23, 2021 and May 1, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 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 VA FLUX, CLOUDY VA, UNCLEAR AND CLINICAL REASON FOR EXPLANT BEING SUBJECTIVE VISUAL DISTURBANCE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT PT UNDERWENT A YAG IN JAN 2023 AND THE LASIK MARCH OF 2023 IN THE LEFT EYE AFTER THE INITIAL IMPLANT. THESE PROCEDURES WERE DONE TO SEE IF THEY WOULD ALLEVIATE PATIENTS COMPLAINTS WITH HER LEFT EYE, AFTER MUCH CONSIDERATION, IT WAS AGREED UPON THAT AN IOL EXCHANGE TO A MONOFOCAL IOL WAS HER BEST OPTION. IN THE SURGEON'S OPINION WHAT CAUSED THE EVENT WAS SUBJECTIVE VISUAL CONCERNS, PATIENTS VISUAL ACUITY WAS GREAT, SHE JUST COULDN'T ADJUST TO THE MODALITY OF THE MULTIFOCAL. LENS WAS EXCHANGED WITH A NON COMPANY LENS. SYMPTOMS RESOLVED. SURGEON'S PROGNOSIS WAS, SO FAR SHE'S ONLY BEEN SEEN ON 4/3 FOR THE 1 DAY POST OP, HEALING WELL, BUT NOT ENOUGH INFO YET.

  Patient problems: Visual Impairment

  MAUDE report 19221980 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE, HALOS AND NO CONTRAST . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 18 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS UNACCEPTABLE QUALITY OF VISION DUE TO GLARE, HALOS, NO CONTRAST . ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 16972557 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED OF VISION UNCLEAR AT ALL RANGES AND CAN¿T READ. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 16476270 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT 50 DAYS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXCHANGED FOR ANOTHER LENS DUE TO A REFRACTIVE ERROR AND NOT ABLE TO SEE WELL.

  Patient problems: Visual Impairment

  MAUDE report 12148651 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED AN EXPLANTED INTRAOCULAR LENS FOR A PATIENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT IN THE SURGEON¿S OPINION, THE PRODUCT CAUSE OR CONTRIBUTE TO THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11789674 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, GLARE AND HALOS. DESCRIBED VISION AS "LIKE LOOKING THROUGH A BOTTLE". THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY TWO MONTHS AFTER THE INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 11712790 ↗