AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652418614), received between Apr 2, 2021 and Nov 22, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH NEAR AND DISTANCE VISION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS LENS WAS NOT CENTERED PROPERLY. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 15842933 ↗
• InjuryMar 22, 2022Adverse 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 HAD NO VISION IMPROVEMENT. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 13853633 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADMINISTRATOR REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING POOR VISUAL RESULT AND WAS UNABLE TO ADAPT THE VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE WITHIN A MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 13512098 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE/ADMINISTRATOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED SYMPTOMATIC GLARE AND HALOS WHILE DRIVING AT NIGHT. THE IOL WAS EXCHANGED FOR A DIFFERENT MANUFACTURER¿S LENS APPROXIMATELY 3 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATED THAT THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED. SYMPTOMS WERE RESOLVED AND THE PROGNOSIS IS GOOD. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THE PATIENT. THIS REPORT IS FOR PATIENT'S LEFT EYE.

  Patient problems: Halo; Visual Impairment

  MAUDE report 12714501 ↗
• InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL)IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INTOLERABLE NIGHT GLARE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT ALSO EXPERIENCED SIGNIFICANT RINGS AT NIGHT. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR A DIFFERENT MODEL IOL WITH 1D DIFFERENCE IN POWER. THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11608237 ↗