AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652418690), received between Apr 23, 2021 and Jul 31, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

• InjuryJul 31, 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 BLURRY VISION. CLINICAL REASON FOR EXPLANT MENTIONED AS REFRACTIVE ERROR. THE IOL WAS EXPLANTED AND EXCHANGED WITH NON COMPANY LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED, PATIENT HAD HALOS AND GLARE AND REPORTED WITH NO PATIENT HARM.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 19870066 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; 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. LENS WAS EXPLANTED DURING SECONDARY PROCEDURE. LENS WAS REPLACED WITH UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 18214113 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REGISTERED NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL COMPLICATION OF INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 16182358 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL SUPERVISOR REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS POOR OVERALL VISION. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 15678851 ↗
• InjuryOct 10, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLURRY DISTANCE VISION, FOREIGN BODY WAS OBSERVED AND THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE PATIENT WAS ALSO ON STEROIDS BUT IT DID NOT HELP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15568857 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRA OCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND ANTI MYOPIA IS THE CLINICAL REASON FOR EXPLANT. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15250510 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLURRED VISION BOTH NEAR AND DISTANCE ALONG WITH THE HALOS AROUND THE LIGHTS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON GIVEN FOR THE EXPLANT WAS MILD IRREGULAR STEEPENING ON TOPOS, WHICH MAY BE PART OF BLURRINESS.ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT HAD EXPERIENCED DRY EYE AND AGGRESSIVE EYE DROPS WERE GIVEN TO HELP WITH IT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Blurred Vision; Dry Eye(s); Halo; Visual Disturbances

  MAUDE report 14209806 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HALOS AND EXPRESSED A NEED FOR BETTER DISTANCE VISION OVER BETTER UP CLOSE VISION, AS WELL AS HALOS. MANY INTERVENTIONS WERE DONE LIKE DROPS, AND PHOTOREFRACTIVE KERATECTOMY (PRK) (5/20). THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. NO PATIENT HARM WAS NOTICED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 14142111 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT VISION WAS WORSE THAN IT WAS BEFORE CATARACT SURGERY BY ABOUT 40%, ACUITY WAS POOR, ESPECIALLY WITH LONG DISTANCE AND NEEDED SPECIAL LIGHT TO READ WELL, ESPECIALLY DURING THE DAY AND PATIENT WEAR GLASSES WHICH HELPS ONLY SLIGHTLY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PATIENT WAS UNHAPPY AND YAG LASER CAPSULECTOMY WAS PERFORMED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13557531 ↗
• InjuryFeb 15, 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 PATIENT VISION WAS WORSE THAN IT WAS BEFORE CATARACT SURGERY BY ABOUT 40%. THE PATIENTS ACUITY WAS POOR, ESPECIALLY WITH LONG DISTANCE AND NEEDED SPECIAL LIGHT TO READ WELL, ESPECIALLY DURING THE DAY. THE PATIENT ALSO WEAR GLASSES WHICH HELPS ONLY SLIGHTLY. THE PATIENT VISION WAS IMPAIRED AND THIS IS NOT WHAT THE CONSUMER WAS EXPECTING. THE PATIENT UNDERWENT YAG (YTTRIUM ALUMINUM GARNET). THE SURGEON PRESCRIBED THE IMMUNOMODULATOR EYE DROPS. THE PATIENT WANTS TO SEE RETINAL SURGEON FOR THE EPI-RETINAL MEMBRANE WHICH IS NO RELATED WITH SURGERY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13534384 ↗
• InjuryDec 1, 2021Adverse 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 GLARE ISSUES AND LENS FLUTTER/FLUCTUATING VISION. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS WITHIN 5 MONTHS AFTER INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 12907532 ↗
• InjuryOct 18, 2021Malposition of Device; Malposition of Device

  A NURSE REPORTED THAT FOLLOWING AN IOL IMPLANT PROCEDURE, THE LENS WAS DECENTERED AND THE PATIENT EXPERIENCED HALOS . THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE FOR A DIFFERENT LENS 2 WEEKS AFTER INITIAL IMPLANTATION.

  Patient problems: Halo

  MAUDE report 12651439 ↗
• InjuryJul 7, 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 EXPLANTED INTRAOCULAR LENS, EXPLANTED LENS, PATIENT FEELS RIGHT EYE VISION IS NOT SHARP, REFRACTIVE ERROR. POST IMPLANTATION AFTER 2 WEEKS THE LENS WAS REPLACED WITH OTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12126974 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED ONE WEEK AFTER IMPLANTATION DUE TO BLURRED VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 11712705 ↗