AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652418744), received between Mar 1, 2021 and Aug 26, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the patient experienced poor vision and halos. Subsequently the lens was removed and replaced with an unspecified monofocal in a secondary procedure. The clinical reason for explant was intolerable to contrast and halos. Additional information has been requested but is not available at the time of this report. There are two Medical Device Reports associated with this report. This is 1 of 2.

  Patient problems: Visual Disturbances

  MAUDE report 50448575 ↗
• InjuryJun 2, 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 (IOL) IMPLANTATION PROCEDURE, THE PATIENT HAD BLURRY VISION AND HALOS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS, "UNABLE TO SEE OUT OF LENS". ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT'S LEFT EYE WAS INVOLVED. A NON COMPANY LENS WAS USED AS A REPLACEMENT LENS. THERE WAS NO PATIENT HARM AFTER LENS REPLACEMENT.

  Patient problems: Blurred Vision; Halo

  MAUDE report 17051515 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED VIA PHONE THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT CLINICAL REASON FOR EXPLANT IS DUE TO HALOS. THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION. LENS IS AVAILABLE FOR RETURN.

  Patient problems: Halo

  MAUDE report 15191882 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED FILM ON THE BACK OF EYE AND DO NOT HAVE GOOD VISION, BAD ISSUES WITH LIGHT. AT NIGHT, ON COMING HEADLIGHTS MAKE IT VERY HARD TO SEE AND GLARE, STARBURST, LIGHT SENSITIVITY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE WITH A NON COMPANY LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING VISION WORSE THAN BEFORE THE OPERATION AND THE STAR BURST EFFECT FROM HEADLIGHTS AT NIGHT MADE IT VERY HARD TO DRIVE AFTER SUNSET. PATIENT HAD NO CHOICE BUT TO HAVE IT REMOVED.

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

  MAUDE report 14957818 ↗
• 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 UNHAPPY WITH VISUAL OUTCOME AND EXPERIENCED GLARE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER FOUR MONTHS OF INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 14839107 ↗
• InjuryMay 29, 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 POOR VISION, DRIVING HALOS AROUND LIGHTS. THE LENS WAS EXCHANGED LATER IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Impairment

  MAUDE report 14538696 ↗
• MalfunctionDec 30, 2021Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A SCRATCH AND PATIENT EXPERIENCED POOR VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE 35 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED

  Patient problems: Visual Impairment

  MAUDE report 13119352 ↗
• InjuryJun 1, 2021Adverse 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) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND HALOS AT NIGHT. THE PATIENT WAS UNHAPPY. THE IOL WAS EXCHANGED APPROXIMATELY 2 MONTHS AFTER THE INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 11913863 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem

  A CUSTOMER SIX PATIENTS EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE'S. A COMPLETED QUESTIONNAIRE WAS RECEIVED INDICATING THE PATIENT EXPERIENCED IRIS PROLAPSE WAS DURING SURGERY. THE PATIENT REQUIRED ADDITIONAL MEDICAL TREATMENT WITH COMPOUNDED ANTIBIOTIC, STEROID AND NON STEROIDAL DROPS IN THE RIGHT EYE. CURRENT PATIENT CONDITION WAS NOT REPORTED. THIS REPORT REPRESENTS PATIENT FIVE OF THE SIX PATIENTS.

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

  MAUDE report 11827157 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED HALOS, GLARE AND VISION WAS NOT CLEAR. THE LENS WAS EXCHANGED WITH A DIFFERENT ONE IN THE SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 11789413 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADMINISTRATOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT WAS UNSATISFIED WITH THE VISUAL RESULTS AND HAD ADAPTATION COMPLICATIONS. THE IOL WAS EXCHANGED APPROXIMATELY ONE MONTH FOLLOWING THE INITIAL IMPLANTATION PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL OF THE SAME POWER. THE SURGEON'S PROGNOSIS WAS REPORTED AS GOOD.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 11633730 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT WAS EXPERIENCING WAVY VISION AND DYSPHOTOPSIA. THE SURGEON REMOVED THE LENS ON A SECONDARY SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 11619611 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED AN INTRAOCULAR LENS (IOL) WAS EXPLANTED 11 MONTHS AFTER IMPLANTATION DUE TO DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 11515638 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PATIENT WAS EXPERIENCING SUDDEN VISION CHANGES. HE LENS WAS REMOVED ON A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11423428 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED GLARE/HALOS WHILE DRIVING AT NIGHT AND BEFORE SUNRISE FOR FOLLOWING INTRAOCULAR LENS IMPLANTATION OF THE LEFT EYE. SHE REPORTED SYMPTOMS ARE WORSE WHILE DRIVING IN THE DARK WHILE IT IS RAINING AND DESCRIBED THE GLARE AS "BLINDING STREAKS OF LIGHTS." SHE ALSO NOTED THAT SHE IS CLOSING HER LEFT EYE TO SEE UP CLOSE, DEPENDING SOLELY ON HER RIGHT EYE. THE LEFT EYE SEEMS SHAKY AT TIMES, LIKE THE LENS IS WIGGLING. SHE INDICATED THAT SHE CONTINUES TO FOLLOW UP WITH HER HEALTHCARE PROVIDER AND LENS IMPLANTATION OF THE RIGHT EYE WAS RECOMMENDED IN ORDER TO "ADJUST FASTER." ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE EYE CARE PROVIDER; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

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

  MAUDE report 11407036 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT THE PATIENT COMPLAINED THAT THE ASTIGMATISM CORRECTION WAS NOT EFFECTIVE. CALCULATIONS WERE DONE FOR ROTATION OF THE LENS SINCE THE IOL WAS MYOPIC; A LENS EXCHANGE WAS PERFORMED TO FULLY CORRECT THE IOL POWER. ADDITIONAL INFORMATION IS REQUESTED.

  Patient problems: No Code Available

  MAUDE report 11396121 ↗