AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30.185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652389945), received between Jan 13, 2022 and Oct 6, 2023 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CONSUMER'S EYES HAVE BEEN ITCHING EVER SINCE. THE PATIENT IS VERY REACTIVE TO ALL PRODUCTS DERIVED FROM CORN AND NEEDS TO KNOW IF ANY CORN DERIVED MATERIALS ARE USED IN THE MANUFACTURING OF THESE LENSES. THE PATIENT CANNOT EVEN GET RELIEF FROM KETOTIFEN EYEDROPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Itching Sensation

  MAUDE report 17884067 ↗
• InjuryDec 28, 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 HE HAD TROUBLE WITH NIGHT DRIVING DUE TO THE RINGS, GLARE, AND HALOS HE SEES AROUND ALL LIGHT SOURCES. HE NOTICED ISSUE SINCE SURGERY. LAST VISIT TO SURGEON AND WAS TOLD I WOULD SUBSIDE OVER THE NEXT SEVERAL MONTHS. THE PATIENT HAS NOT NOTICED ANY IMPROVEMENT. 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 16059167 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED GHOSTING AND GLASSES/CONTACTS AND DOUBLE VISION. THE LENS WAS EXCHANGED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 15850886 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, HIS VISION WAS HORRIBLE, ALMOST FELT LIKE HIS VISION WAS LOST. A MEDICAL INTERVENTION WAS CARRIED OUT WHICH WAS NOT EXPLAINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHERE THE CONSUMER STATES THEY PROBABLY PUT THE WRONG LENSES AND VISION WAS GROSSLY AFFECTED RESULTING IN LOSS OF EMPLOYMENT AMONG OTHERS.

  Patient problems: Visual Impairment

  MAUDE report 14871110 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXCHANGED, AS PATIENT FELT DISCOMFORT BY CONTINUOUS VISION DECLINE FROM UNKNOWN CAUSES AFTER SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 13250241 ↗