AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652429702), received between Jan 27, 2023 and Feb 27, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, SEVEN DAYS AFTER SURGERY, THE PATIENT DESCRIBED THEIR VISION WAS LOOKING LIKE THROUGH A SMUDGE OF VASELINE IN BOTH EYES. SO, THE PATIENT HAD LASER SURGERY. SURGEON SAID THAT THE PATIENT HAD AN OCCIPITAL GLIOMA. ADDITIONALLY, THE PATIENT UNDERWENT MANY NEURO STUDIES (NEUROLOGICAL MOTOR/SENSORY FINDINGS (MDS)) AND SCAN SHOWED NEGATIVE RESULTS (DID NOT HAVE OCCIPITAL GLIOMA OR EYE RELATED MULTIPLE SCLEROSIS). FURTHERMORE, ALL EYE EXAMINATION SHOWN NORMAL RESULTS AND THERE WAS NO EYE PAIN, BUT NOTHING WAS CLEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 24470362 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TROUBLE READING AND DIFFICULTY WITH BRIGHT LIGHT. THE IOL WAS EXCHANGED FOR A NON-COMPANY LENS 2 YEARS, 11 MONTHS, AND 5 DAYS AFTER THE INITIAL IMPLANT PROCEDURE, AND THE PATIENT WAS DOING WELL. SHE WAS HAPPY WITH THE RESULT AND WANTED TO MAKE NOTE THAT PEOPLE WITH MIGRAINES SHOULD NOT BE CONSIDERED CANDIDATES FOR MULTIFOCAL LENSES. THE PATIENT'S NEUROLOGIST HAD STATED, NEVER MESS WITH THE VISUAL STIMULATION OF A MIGRAINE SUFFERER.

  Patient problems: Blurred Vision; Halo; Photophobia

  MAUDE report 22302157 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAS TROUBLE READING, SEEING DISTANCE, CAN'T DRIVE AT NIGHT. SHE NOTES FLICKERING AND NEW FLOATERS. HAS TROUBLE SEEING IN DIM LIGHTS IN THE HOUSE. SHE NOTICES HER OTHER EYE IS DOING ALL THE WORK. SHE IS SEEING BETTER THROUGH HER WEAKER EYE. HER SURGEON WAS SURPRISED AND COULD NOT FIGURE OUT WHAT THE ISSUE FOR HER IS. THERE WAS NOTHING WRONG WITH THE LENS OR HER EYE AS FAR AS HE COULD TELL. HE GAVE HER A GLASSES PRESCRIPTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT HAD VISION ISSUES ONE MONTH POST IMPLANTATION. IN THE SURGEON'S OPINION, THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances; Vitreous Floaters

  MAUDE report 18825623 ↗
• InjuryFeb 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NURSE REPORTED ABOUT AN INTRAOCULAR LENS (IOL) EXPLANT DUE TO PATIENT EXPERIENCED POOR QUALITY VISION WITH BEST CORRECTED VISUAL ACUITY (BCVA). THE CLINICAL REASON WAS REPORTED TO BE IOL WAS TILTED WITH INTERIOR OPTIC OUT OF THE BAG AND MILD SUPERIOR DISLOCATION. THE IOL WAS REPLACED WITH MONOFOCAL LENS APPROXIMATELY TWO MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 18702893 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT ALSO COMPLAINED ABOUT HALOS.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17423151 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT, AFTER A MONTH OF SURGERY THE PATIENT STARTED HAVING THE SYMPTOMS. IT WAS ALSO STATED CANT SEE AND IT WAS EVERYTHING BLURRED.

  Patient problems: Blurred Vision; Halo; Irritability; Red Eye(s)

  MAUDE report 16253625 ↗
• InjuryJan 27, 2023Adverse 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 EXPERIENCED HALOS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER 6 MONTHS OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS DISSATISFACTION WITH PRESBYOPIC IOL. THE LENS WAS REPLACED WITH MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Impairment

  MAUDE report 16251880 ↗