AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT50 (REF TFNT50.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652391139), received between Dec 13, 2022 and Dec 13, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2022Adverse 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 HAD LIGHT REFLECTIONS, HALOS AND STARBURST. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, SINCE THE FIRST DAY AFTER THE SURGERY PATIENT SEE VERY DISTURBING LIGHT RINGS AND HALOS AS WELL AS GLARE AND STARBURST AROUND LIGHT SOURCES, ESPECIALLY INTENSE IN THE DARK, E.G. STREET LAMPS, TRAFFIC LIGHT, CAR HEADLIGHTS/TAIL LIGHTS, BICYCLE LIGHTS AND OTHER LIGHT REFLECTIONS; ESPECIALLY INTENSE WITH WHITE POINT-SHAPED LIGHT SOURCES (WITHOUT OR WITH VARIFOCALS NO DIFFERENCE). THEY ARE NOT ONLY ANNOYING, BUT ALSO DANGEROUS, ESPECIALLY BY CAR TRIPS DURING THE DARK. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15967916 ↗