AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652429696), received between Jan 9, 2023 and May 7, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2024Material Deformation; Material Deformation

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE , HALOS, DECREASED BEST CORRECTED VISUAL ACUITY DUE TO GLISTENINGS. THE LENS WAS PLANNED TO BE EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS GLISTENING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 19258337 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT'S EYES WERE FAILING AND PATIENT WAS UNHAPPY WITH THE RESULTS. THE VISION NEVER GOT CORRECTED PERFECTLY AND THE READING VISION WAS DECREASED OVER LAST TWO MONTHS. THE PATIENT UNDERWENT POSTERIOR CHAMBER YTTRIUM-ALUMINUM-GARNET LASER AROUND A YEAR OR SO AGO. PATIENT'S OPTOMETRIST DID NOT SEE ANYTHING THAT WOULD WARRANT VISION CHANGE AND PRESCRIBED TO WEAR GLASSES. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 17808945 ↗
• InjuryAug 3, 2023Adverse 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 COMPLAINED OF GLARE AND RINGS AT NIGHT AND PATIENT WAS UNHAPPY WITH THE VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 7 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MALFUNCTION OF IOL. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT ALSO EXPERIENCED HALOS AT NIGHT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17450252 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE IOL WAS EXCHANGED FOR AN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 17077046 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE VISION HAS IMPROVED AND THE PATIENT WEARS GLASSES. THE VISION CORRECTED TO 20/25 AND THIS IS WHERE VISION WILL REMAIN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16254600 ↗
• InjuryJan 9, 2023Output Problem

  I HAD A PANOPTIX INTRAOCULAR LENS PLACED IN MY RIGHT EYE ON (B)(6) 2021. MY VISION PRIOR TO THE SURGERY WAS CORRECTABLE TO 20/20. MY RIGHT EYE VISION IS NOW BLURRY AND CANNOT BE CORRECTED TO 20/20. I HAVE HAD SEVERAL FOLLOW-UP VISITS WITH MY OPHTHALMOLOGIST AND YESTERDAY SHE SAID NOTHING MORE CAN BE DONE. CONSUMERS SHOULD BE NOTIFIED THAT A SMALL PERCENTAGE OF RECIPIENTS OF THIS IMPLANT WILL HAVE WORSE VISION THAN BEFORE THE SURGERY AND THAT IT IS A PERMANENT RESULT. I WAS NOT INFORMED OF THIS.

  Patient problems: Blurred Vision

  MAUDE report 16132383 ↗