AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652418683), received between Apr 21, 2021 and Jun 7, 2024 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2024Optical Decentration; Optical Decentration

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRED VISION FROM THE TIME HE/SHE LEFT HOSPITAL. CONSUMER WAS TOLD BY PHYSICIAN FROM EYE CENTER THAT THE IMPLANT MOVED AND NEEDED ANOTHER SURGERY TO CORRECT IT. CONSUMER HAD SURGERY AND STILL HAD BLURRED VISION. THE DOCTOR HAS NOT FIXED THE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED PATIENT HAD BLURRED VISION AFTER FIRST SURGERY AND AFTER SECOND SURGERY FOR REALIGNMENT. EXTREMELY BLURRED IN LOW LIGHT CONDITIONS, COULD NOT DRIVE ANYMORE AT NIGHT. THE PATIENT HAD DISCUSSED WITH PHYSICIAN. PHYSICIAN RESPONSE WAS SECOND SURGERY WHICH DID NOT CORRECT PROBLEM. NOW TOLD CONSUMER TO GET A CONTACT LENS WITH NO PRESCRIPTION FROM OPTOMETRIST WHICH WAS NOT AVAILABLE. ALSO PRESCRIBED EYE DROPS TO MAKE PUPILS SMALLER WHICH THE CONSUMER HAS NOT GOTTEN YET.

  Patient problems: Blurred Vision

  MAUDE report 19482962 ↗
• InjuryMar 27, 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 PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH A OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL COMPLICATIONS. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Blurred Vision

  MAUDE report 16618581 ↗
• InjuryFeb 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED WITHIN 1 WEEK AFTER IMPLANTATION DUE TO BLURRY VISION AND IOL DISLOCATION. THE IOL WAS REPLACED WITH ANOTHER IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 13511905 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION AFTER A YEAR THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO PATIENT NOT BEING ABLE TO SEE INTERMEDIATELY OR AT NEAR. THE LENS WAS REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 13167540 ↗
• InjuryOct 26, 2021Adverse 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 LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12696571 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS PROVIDED THAT THE IMMEDIATELY AFTER PLACEMENT OF THE LENSES ON (B)(6) 2020, THE ASTIGMATISM WAS NOT CORRECTED. THE DOCTOR DID YAG LASER WHICH DID NOT HELP. LATER THE TOUCH UP LASIK WAS DONE ON (B)(6) 2021, WHICH CORRECTED THE RESIDUAL ASTIGMATISM BUT THE INTERMITTENT BLURRY AND HAZY VISION CONTINUES. DOCTOR PLACED THE PUNCTUAL PLUGS ON (B)(6) 2021, PATIENT STILL HAVING INTERMITTENT GOOD AND BAD VISION, AND MOSTLY BAD. SOME DAY¿S PATIENT READ NEWSPAPER AND STREET SIGN AND SOME DAYS PATIENT CAN'T. PATIENTS POOR VISION CAN'T BE CORRECTED WITH GLASSES. PATIENT HAS NOT BEEN DIAGNOSED WITH MACULAR EDEMA, BUT IS GOING ON 10/28 FOR FURTHER TESTING.

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

  MAUDE report 12517992 ↗
• InjuryAug 26, 2021Malposition of Device; Malposition of Device

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE PATIENT HAD EXPERIENCED MODERATE BLURRED VISION, WITH SECONDARY HYPEROPIA OF RIGHT EYE AND MALPOSITION OF INTRAOCULAR LENS. THE LENS WAS EXPLANTED AND EXCHANGED FOR A SAME MODEL WITH A DIFFERENT DIOPTER VALUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12370924 ↗
• InjuryJul 8, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED AN EXPLANTED INTRAOCULAR LENS WITH A PATIENT REASON FOR EXPLANT OF BLURRED VISION, GLARE AND HALOS, AND A CLINICAL REASON FOR EXPLANT OF LENS MALFUNCTION. ADDITIONAL FOLLOW UP REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 12135103 ↗
• MalfunctionMay 27, 2021Defective Device; Scratched Material; Defective Device; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT, NOTICED A SCRATCH ON THE CENTER OF THE INTRAOCULAR LENS (IOL) FOLLOWING IMPLANTATION AND HAPTIC ISSUE. THE LENS WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892498 ↗
• MalfunctionApr 21, 2021Scratched Material; Scratched Material

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAD DEBRIS IN THE CENTER OF THE LENS WHICH MADE THE POSTOPERATIVE MEASUREMENTS INACCURATE. NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION PROVIDED INDICATES THAT THE DEBRIS WAS A SCRATCH OR CRACK IN THE IOL. THE IOL REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699551 ↗