AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652418768), received between Jun 16, 2021 and Sep 27, 2022 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NURSE REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO READ SMALL PRINT AND STREET SIGNS. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT, THE IMPLANT WAS SLIGHTLY OFF AXIS AND INSUFFICIENT POWER. THERE WAS NO PATIENT HARM INVOLVED. THE PATIENT WAS NOT HOSPITALIZED.

  Patient problems: Visual Impairment

  MAUDE report 15494305 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT HAD HALOS AND FEELS DANGEROUS TO DRIVE. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT ISSUES WERE RESOLVED AND THE SURGEON'S PROGNOSIS WAS GOOD.

  Patient problems: Halo

  MAUDE report 15157151 ↗
• MalfunctionMay 13, 2022Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 14396403 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE ON (B)(6) 2021 IN HER LEFT EYE, SHE EXPERIENCED BLURRINESS AND SEVERE DRY EYE. IT HAS INTERFERED WITH QUALITY OF LIFE, DRIVING AND PERFORMANCE AT WORK. THE VISION GOT WORSE. IT WAS LIKE HAVING A CLOUD OR FOG IN FRONT OF EYE. SHE ALSO DEVELOPED SCAR TISSUE WHICH WAS ALSO GIVING ME DISTORTION IN ADDITION TO THE BLURRINESS AND FLOATERS. SHE CONSULTED 3 OPHTHALMOLOGIST AND 2 RETINA SPECIALIST, BUT NO ONE WERE ABLE TO MAKE OUT THE CAUSE OF HER BLURRY VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Dry Eye(s); Scar Tissue; Visual Impairment; Vitreous Floaters

  MAUDE report 14355161 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD POOR DISTANCE AND READING VISION. POST OPERATIVE HYPEROPIA. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 14235736 ↗
• InjuryNov 12, 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 BLURRED VISION AND VISION DISTORTION. THE IOL EXCHANGED FOR ANOTHER LENS (ANOTHER MODEL) APPROXIMATELY 6 WEEKS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT'S SYMPTOMS WERE NOT RESOLVED (STILL STROMAL EDEMA). THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12802565 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, FLASHES OF LIGHT, AND COULD NOT SEE. SEVEN DAYS FOLLOWING THE INITIAL PROCEDURE, THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Flashers

  MAUDE report 12168052 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANTATION AFTER ONE MONTH THE LENS WAS EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 12007688 ↗