AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652418775), received between Apr 16, 2021 and Jul 8, 2024 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• InjuryJul 8, 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 BLURRED VISION. CLINICAL REASON FOR EXPLANT MENTIONED AS MECHANICAL COMPLICATION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19690152 ↗
• InjuryMar 15, 2024Adverse 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 SUBJECTIVE VISUAL DISTURBANCE, DAYTIME HALOS, BLURRED VISION AND DAYTIME STARBURSTS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT UNDERWENT YTTRIUM ALUMINUM GARNET (YAG) BEFORE EXPLANT. SURGEON¿S PROGNOSES INCLUDE GOOD POST OPERATIVE APPEARANCE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18913867 ↗
• InjurySep 15, 2023Adverse 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 HAD BLURRED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 17756552 ↗
• InjuryJan 20, 2023Adverse 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 EXPERIENCED BLURRED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER SIX MONTH OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS HYPEROPIC OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16213399 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADMINISTRATOR REPORTED THAT APPROXIMATELY AFTER 4 MONTHS OF IMPLANTATION OF AN INTRAOCULAR LENS (IOL), EXPLANTED INTRAOCULAR LENS DUE TO UNABLE TO ADAPT BLURRY VISION. LENS WAS REPLACED WITH DIFFERENT LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15238774 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OPHTHALMOLOGIST REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION DUE TO MECHANICAL COMPLICATION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14314606 ↗
• MalfunctionFeb 22, 2022Failure to Unfold or Unwrap; Difficult to Advance; Failure to Unfold or Unwrap; Difficult to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS PARTIALLY DEPLOYED, HANDED BACK TO TECHNICIAN TO RELOAD. AFTER THE LENS WAS REMOVED FROM CARTRIDGE, THE LENS WAS CRIMPED AND WOULD NOT UNFOLD. PROCEDURE WAS COMPLETED WITH THE SAME LENS WITH NO FURTHER ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576821 ↗
• MalfunctionApr 16, 2021Crack; Crack

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE A CRACK/SCRATCH WAS NOTED ON THE LENS AFTER INSERTING IN THE EYE. THE LENS WAS REMOVED AND A NEW LENS WAS IMPLANTED WITHOUT INCIDENT. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679513 ↗