AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652429726), received between May 12, 2022 and May 28, 2024 — classified as 12 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DIFFICULTY IN DRIVING AT NIGHT AND READING. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS SIGNIFICANT NEGATIVE DYSPHOTOPSIA DUE TO COMPLICATIONS WITH EXISTING MULTI-FOCAL IOL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 19404658 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) THE PATIENT HAD INTOLERANCE OF IMPLANTED MULTIFOCAL LENS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE SURGEON WAS TOLD THAT HE LIKELY HAS ISCHEMIC OPTIC NEUROPATHY THAT BEGAN AROUND THE TIME OF CATARACT SURGERY. THE SURGEON WAS SOMEWHAT SUSPICIOUS OF VITAMIN D DEFICIENCY IN THE PATIENT. THE PATIENT HAD BLOOD WORK DONE ON (B)(6) 2023. THE PATIENT WAS NOT TOLERATING HIS LENSES. I REFRACTED THE PT AND HE TRIALED FRAME THAT PRESCRIPTION. THE SURGEON FELT THAT IT DIDN'T MAKE MUCH DIFFERENCE AND FELT IT UNNECESSARY FOR HIM TO WEAR CORRECTION. THE SURGEON FURTHER DISCUSSED TREATMENT OPTIONS AND HOW REFRACTIVE SURGICAL CARE WOULDN'T BE A BENEFIT TO HIM. THE SURGEON ALSO DISCUSSED IOL EXCHANGE TO WHICH HE PROCEEDED WITH THIS AND SVD IOLS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300623 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT TOLERATE HALOS AND GLARE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS FAILURE TO ADAPT.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17827951 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT TOLERATE HALOS AND GLARE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS FAILURE TO ADAPT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH 1 OF 2.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17827665 ↗
• InjuryJun 26, 2023Adverse 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 HAS DISABLING GLARE AT NIGHT AND DECREASED QUALITY OF VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER SIX MONTHS OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 17203975 ↗
• InjuryJun 9, 2023Adverse 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 VISION BLURRY AND UNABLE TO NEURO ADAPT TO TECHNOLOGY OF EXTENDED FOCUS . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 7 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS PATIENT UNHAPPY WITH VISION FROM INITIAL IOL. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17097863 ↗
• MalfunctionMay 8, 2023Failure to Advance; Scratched Material; Failure to Advance; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INJECTING LENS INTO PATIENT¿S EYE, LENS WAS STUCK ONTO THE MIDDLE OF THE PLUNGER WHICH SCRATCHED THE LENS. THERE WAS PATIENT CONTACT OBSERVED. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16884210 ↗
• InjuryMar 27, 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 HAD INTOLERABLE VISUAL ABERRATIONS AND GLARE. THEREFORE, THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH NON COMPANY MONOFOCAL LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT WAS TREATED WITH YAG LASER POSTERIOR CAPSULOTOMY AFTER SURGERY. PATIENT VISION WAS IMPROVED BUT NOT GREAT. SHE STATED VISION WAS BETTER AT DISTANCE THAN NEAR, THOUGH IT WAS PRETTY BLURRY EVERYWHERE. SHE COULD READ TABLET WHEN MAKING FONT LARGER, BUT COULD NOT READ BOOK, COULD NOT READ SUBTITLES ON THE TV. SHA HAD SNOWFLAKES AND STARBUST WHEN DRIVING AT NIGHT. THERE WERE FLOATERS IN THE RIGHT EYE. PATIENT ALSO HAD DERMATOCHALASIS, TRACE BLEPHARITIS ANTERIOR AND TRACE BLEPHARITIS POSTERIOR, CONJUNCTIVA- TRACE INJECTION AND PINGUECULUM, VITREOUS DETACHMENT, MILD ASYMMETRIC SURFACE ON TOPOGRAPHY WITH FEW PERIPHERAL MICROCYSTS, TRACE MEIBOMIAN GLAND DYSFUNCTION, MILD EYE PAIN AND DRY EYES. THE PATIENT HAD BEEN ADVISED TO TAKE, ANTIBIOTIC, NSAIDS AND STEROID DROPS. PATIENT COND

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Eye Pain; Visual Disturbances; Visual Impairment; Vitreous Detachment; Vitreous Floaters

  MAUDE report 16619312 ↗
• InjuryMar 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM AND PATIENT ISSUES WERE RESOLVED, AND NOW THE PATIENT WAS HAPPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 16527281 ↗
• InjuryMar 10, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION (IOL) IT WAS NOTICED THAT THE 80% OF THE HAPTIC WAS BISECTED. THE PATIENT HAD EXPERIENCED GLARE AND HALOS. HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE OPTIC WAS 80-90% BISECTED (CLEAN) AT THE OPTIC/HAPTIC JUNCTION. THE PATIENT SYMPTOMS HAVE RESOLVED AND THE PROGNOSIS WAS EXCELLENT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.

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

  MAUDE report 16521574 ↗
• 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 MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15995124 ↗
• InjuryDec 7, 2022Adverse 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 CANT SEE WELL. CLINICAL REASON FOR EXPLANT IS INTOLERANT OF DECREASED CONTRAST. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED IN THE SURGEONS OPINION INTOLERANT OF DECREASED CONTRAST IS THE CAUSE OF THE EVEN. EVENT RESOLVED, THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15931498 ↗
• MalfunctionNov 23, 2022Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15850892 ↗
• InjuryMay 12, 2022Adverse 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 BLURRY VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE AND CLINICAL REASON FOR EXPLANT OF UNDESIRED VISUAL PHENOMENA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 14377042 ↗