AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652415552), received between Sep 9, 2021 and Nov 4, 2022 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), SHE HAD VERY POOR VISION, BLURRY, FOGGY, NO CLARITY, EXTREME LIGHT SENSITIVITY, EQUILIBRIUM IMBALANCE, LIGHT HEADED, NAUSEA AND OCULAR MIGRAINES. SHE WAS HAVING EYE PRESSURE PROBLEMS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH A NON COMPANY LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 15733453 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN EYE CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HALOS CONCENTRIC CIRCLES. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Halo

  MAUDE report 13119230 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT READ OR COULD NOT SEE DISTANCE AND MYOPIC SURPRISE. THE IOL EXCHANGE WILL BE SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12897829 ↗
• InjurySep 9, 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) IMPLANT PROCEDURE, PATIENT EXPERIENCED INCREASED GLARE AND THE NIGHT VISION WAS ALSO WORSENED. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE.

  Patient problems: Visual Disturbances

  MAUDE report 12445095 ↗