AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652418720), received between Aug 25, 2021 and Apr 1, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Material Opacification” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED DECREASED VISION. THE IOL WAS REPLACED WITH MONOFOCAL LENS APPROXIMATELY THREE YEARS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 19011673 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18756948 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HALOS, POOR VISION AND GLARE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16290492 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE VISION WAS POOR FOR A LONG WHILE EYE WAS VERY SENSITIVE TO LIGHT, NEEDED GLASSES TO READ, LONG DISTANCE WAS VERY POOR, BUT HALOS WAS VERY DISTRACTING. THE COLORS ARE WASHED OUT, HAD SIGNIFICANT TEARING AND BURNING AFTER SURGERY, THE LOCAL EYE AND SINUS PAIN WAS PRESENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT RIGHT EYE VISION WAS IMPROVED SOMEWHAT OVER ABOUT 9 MONTHS AND THEN PLATEAUED, LONG-DISTANCE VISION REMAINS WORSE THAN LEFT EYE, GLARE/HALOS ARE SO SEVERE, STILL NEED GLASSES FOR READING/COMPUTER, THE PILOCARPINE HCL WAS PRESCRIBED WHICH REDUCES THE PUPIL OPENING. IT REDUCED THE GLARE BUT ALSO REDUCED ALREADY WEAK DISTANCE VISION, PATIENT WAS NOT ABLE TO DRIVE. BUT THE NEAR VISION BECOME AMAZINGLY SHARP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Eye Pain; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15940574 ↗
• InjuryNov 17, 2022Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION CLOSE AND FAR, CLOUDY VISION BOTH NEAR AND FAR, HARD TO SEE, NOT REALLY FLOATERS BUT LIKE ALWAYS LOOKING THROUGH A FOG, NOT HAPPY AND ALSO LASER AFTER THE SURGERY, THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH LET EYE.

  Patient problems: Blurred Vision; Dry Eye(s); Vitreous Floaters

  MAUDE report 15812532 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING AN INTRA OCULAR LENS IMPLANT PROCEDURE, THE PATIENTS HAS EXPERIENCED MULTIPLE SHIFT AND BLURRY VISION. THE LENS WAS LATER EXCHANGED WITH A MONO FOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15320609 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGEMENT REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED APPROXIMATELY 2 MONTHS AFTER IMPLANTATION DUE TO DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 14621218 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCE PHOTOPHOBIA AND HALOS. THE LENS WAS EXCHANGED APPROXIMATELY AFTER 3 MONTHS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12966773 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT INTRAOCULAR LENS WAS IMPLANTED PROCEDURE THE PATIENT EXPERIENCED BLURRY VISION, NAUSEOUS AND POOR SUBJECTIVE VISION HALOS NIGHT VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Halo; Nausea

  MAUDE report 12933135 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. THE SYMPTOMS WERE RESOLVED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12868133 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE, GHOSTING, RINGS IN VISION, DYSPHOTOPSIA. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 12799137 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGICAL COORDINATOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT SEES SPIKES AND CIRCLES AROUND LIGHTS AT NIGHT AND SOMETIMES COULD NOT TELL WHERE THE LIGHTS WERE ON THE ROAD AND SHE CAN NO LONGER DRIVE. THE IOL WAS EXCHANGED FOR A DIFFERENT LENS MODEL 4 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12513294 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INTOLERABLE NIGHT VISION, GLARE AND HALOS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT COULD ALSO SEE RINGS. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL WITH DIFFERENT CYLINDRICAL POWER, IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 12373724 ↗
• InjuryAug 25, 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 RINGS AND HALOS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOUR MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12364767 ↗