AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652418560), received between Mar 31, 2021 and Jul 4, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

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.

• MalfunctionJul 4, 2022Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14906659 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY, HALOS, FLICKERS, ASTIGMATISM, IRRITATION, WEIRD FLASHES AND SINUS ISSUE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT COULD ALSO GOT MILD POSTERIOR CAPSULE OPACIFICATION, FOREIGN BODY SENSATION IN CONJUNCTIVAL, TRICHIASIS AND WAS PRESCRIBED WITH ANTIBIOTICS, HE ALSO GOT EPILATION, ALSO HAD MYOPIA, PRESBYOPIA, FOGGY VISION, MILD DISCOMFORT AND SORENESS. NO FURTHER INFORMATION AVAILABLE. 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; Blurred Vision; Discomfort; Foreign Body Sensation in Eye; Halo; Headache; Nerve Damage; Visual Disturbances; Visual Impairment

  MAUDE report 14247833 ↗
• MalfunctionNov 30, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED VIA A REPLY CARD THAT THE INTRA OCULAR LENS (IOL) WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12889935 ↗
• InjuryMar 31, 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, THERE IS A PLANNED IOL EXCHANGE. ADDITIONAL INFORMATION WAS PROVIDED BY THE PHYSICIAN THAT THE PATIENT REPORTED FLUCTUATION IN VISION, GLARE, HALOS, BLURRED VISION IN ALL DISTANCES, STARBURSTS, ALL IMPACTING DAILY LIFE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 11595947 ↗