AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40 (REF TFAT40.185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652419208), received between Aug 16, 2021 and Jul 1, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Positioning Failure” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 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'S VISION WAS LIKE SEEING THROUGH VASELINE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19643008 ↗
• InjuryJul 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINT OF DECREASED VISION. THE DECREASED VISION WAS AT A DISTANCE AND CONSTANT AND ASSOCIATED WITH FOREIGN BODY SENSATION AND PHOTOPHOBIA. THE DECREASED VISION HAS BEEN PRESENT FOR 1 WEEK AND PATIENT BEING TREATED LUBRICATE DRY EYES AND ANTI-INFLAMMATORIES. IN POST OFF 2ND VISIT PATIENT COMPLAINT OF FOREIGN BODY SENSATION. THE YAG (YTTRIUM ALUMINUM GARNET) LASER POSTERIOR CAPSULOTOMY PERFORMED FOR POSTERIOR CAPSULAR OPACIFICATION. POST YAG PATIENT COMPLAINT ABOUT INTERMEDIATE WAS BLURRY AND HAS TROUBLE FOCUSING, CAUSING DIZZINESS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT HAD COMPLICATED CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE INITIALLY. PATIENT HAD AN EXPLANT, ANTERIOR VITRECTOMY, INFERIOR FOVEA SPLITTING RHEGMATOGENOUS RETINAL DETACHMENT (RRD). FOLLOWED BY A PARS PLANA VITRECTOMY AND PATIENT NOW DOING WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dizziness; Eye Pain; Foreign Body Sensation in Eye; Retinal Detachment; Visual Disturbances; Visual Impairment

  MAUDE report 14907325 ↗
• InjuryMay 29, 2022Positioning Failure; Positioning Failure

  A HEALTHCARE PROFESSIONAL REPORTED AN EXPLANT HAS BEEN PLANNED DUE TO NO LONGER CAN SEE CLEAR OUT OF OS, FEELS ALWAYS BLURRY AND NOT CLEAR. THE LENS WAS OFF POSITIONED AND SHIFTED UPWARDS, THEREFORE TO ATTAIN THE CORRECT VISION THE LENS WAS ALTERED WITH MORE ASTIGMATISM THEN WANTED AT A +1.50. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14538688 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION THE PATIENT WAS SEEING HALOS. THE IOL WAS EXCHANGED FOR A DIFFERENT IOL APPROXIMATELY AFTER 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Halo

  MAUDE report 12328428 ↗