AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652418737), received between Jun 28, 2021 and May 9, 2023 — classified as 10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT WAS UNABLE TO TOLERATE THE IMPLANT, PATIENT HAD POOR QUALITY OF VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS. THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 16893983 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED FOLLOWING IMPLANTATION OF INTRAOCULAR LENS, THE PATIENT'S VISUAL OUTCOME WAS NOT AS EXPECTED. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER MODEL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15995388 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED HALOS WHICH OBLITERATED HER EARLY EVENING AND NIGHT VISION. THE HALOS WERE SO BIG TAKING OVER THE ENTIRE ROAD. SHE COULD NOT SEE TO SAFELY MAKE TURNS. THOUGH AFTER WAITING THE APPROPRIATE SETTLE-IN TIME SUGGESTED BY HER DOCTOR, HALOS DID NOT GO AWAY. HER EYES FELT LIKE THEY WERE UNDER WATER ALL THE TIME. ADDITIONAL INFORMATION WAS RECEIVED STATING SHE EXPERIENCED HALOS FRONT THE START, THINGS FELT BLURRIER AND HER DEPTH PERCEPTION WAS OFF. THE LOW CONTRAST WAS DISCONCERTING WHEN DRIVING AND SHE HAD TO BUY SEVERAL PAIRS OF DIFFERENT SUNGLASSES TO HELP PROVIDE MORE CONTRAST. LOW LIGHT INDOORS WAS NOT GOOD. SHE HAD TUMBLED OFF A STAIRCASE TWICE BECAUSE SHE COULD NOT SEE THE LAST STEP. SHE WAS SO DISAPPOINTED WITH THE OUTCOME OF HER SURGERIES. SHE WAS HOPING THAT THE HALOS WILL GO AWAY. SHE WAS NOT BEING ABLE TO DRIVE HOME AT NIGHT. THE HALOS OBLITERATE THE VIEW ON THE ROAD IN THE DISTANCE GROWING LARGER AND LARGER AS VEHICLES GET CLOSER. THE AREA OF THE HALO WAS LARGER THAN THAT OF THE CAR, REACHING ABOVE, BELOW AND LEFT AND RIGHT SIDES, SPI

  Patient problems: Blurred Vision; Excessive Tear Production; Eye Pain; Halo; Headache; Hyporesponsive to stimuli; Visual Disturbances; Visual Impairment

  MAUDE report 15751878 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISUAL ACUITY AND GHOSTING IMAGES WHEN READING. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS RESIDUAL ASTIGMATISM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE ONE OF THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 15218863 ↗
• InjuryAug 8, 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 EXPERIENCED BLURRED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 8 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15181870 ↗
• MalfunctionJun 30, 2022Defective Device; Defective Device

  AN OTHER-HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), NOTED THE EDGE OF LENS WAS CHIPPED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 14870145 ↗
• InjuryJun 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 EXPERIENCED BLURRED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER SEVEN MONTHS OF INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 14839108 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT UNHAPPY WITH THE VISION. THE PATIENT INCISION WAS ENLARGED AND SUTURE FOR INCISION HAD DONE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 3 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury; Visual Disturbances

  MAUDE report 13468929 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED GLARE, HALOS, STARBURSTS. POST IMPLANTATION AFTER SIX MONTHS THE LENS WAS REPLACED WITH OTHER MODEL LENS.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12237613 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT¿S EXCHANGES WERE INITIALLY PLANNED FOR JUNE, BUT AT THAT TIME EXPLANTATION WAS NOT DONE.

  Patient problems: Dry Eye(s); Visual Impairment

  MAUDE report 12110668 ↗
• InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED AN EXPLANTED INTRAOCULAR LENS WITH A PATIENT REASON FOR EXPLANT OF, VA APPEARS AS IF WORDS HAVE BEEN WRITTEN AND ERASED, GLARE AT NIGHT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 12080098 ↗