AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652429733), received between Dec 6, 2022 and May 1, 2025 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Adverse 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 WAS UNABLE TO ADAPT. CLINICAL REASON FOR EXPLANT WAS UNABLE TO ADAPT ON MULTIFOCAL INTRAOCULAR LENS (MF IOL). THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 04 MONTHS 25 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21943155 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT PATIENT EXPERIENCED GLARE, HALOS AND CLINICAL REASON BEING HYPERPHORIA. THE IOL WAS PLANNED TO BE EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 18639000 ↗
• InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED AN THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HALOS AND GLARES . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 7 MONTHS FOURTEEN DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18203783 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT HALOS AROUND THE LIGHTS DURING DAY AND NIGHT AND BLURRY DISTANCE VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS PATIENT DID NOT ADAPT TO LENS.

  Patient problems: Blurred Vision; Halo

  MAUDE report 17905235 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT HAS NOT NOTICED ANY IMPROVEMENT WITH VISION. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS FUCH'S CORNEAL DYSTROPHY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, IN THE SURGEON'S OPINION THE QUALITY ISSUE WITH THE LENS DID NOT CAUSE THE EVENT BUT THE INTERMITTENT FLOATERS WAS THE CAUSE OF THE EVENT. THERE WAS NO PATIENT HARM, AND THE PROGNOSIS OF THE PATIENT WAS GOOD.

  Patient problems: Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 17734765 ↗
• MalfunctionApr 18, 2023Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SCRATCH WAS NOTED IN THE MIDDLE OF THE LENS, THERE WAS A PATIENT CONTACT, AND THE PROCEDURE IS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16759854 ↗
• MalfunctionApr 6, 2023Break; Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION CHUNK WAS MISSING FROM THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16690946 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT IMMEDIATELY AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED CLOUDY AND BLURRY VISION. THE PHYSICIAN HAD PERFORMED TWO LASIK PROCEDURES TO CORRECT VISION. THE REPORTER MENTIONED THAT VISION WAS GETTING WORSE AND STILL FELT CLOUDY, LOTS OF FLOATERS AND BLURRY SPOTS. ADDITIONALLY THE PATIENT CANNOT SEE CLOSE NOR DISTANCE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT HAD BLURRY, HAZY, CLOUDY AND SIGNIFICANT REDUCED VISION, GLARE, HALOS AND BLACK AND TRANSLUCENT FLOATERS.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Vitreous Floaters

  MAUDE report 16576607 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT HAD BLURRED VISUAL ACUITY. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS. THE CLINICAL REASON FOR EXPLANT WAS UNSATISFACTORY VISUAL PERFORMANCE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 16291801 ↗
• InjuryJan 20, 2023Adverse 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 LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS REFRACTIVE SURPRISE. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT'S SYMPTOMS WERE RESOLVED. THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 16214540 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO ADAPT TO THE LENS. THE IOL WAS EXPLANTED AND EXCHANGED IN A SECONDARY PROCEDURE FOR MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15932143 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT ADJUST. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL FAILURE TO ADAPT. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 15926146 ↗