AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40.135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652390392), received between Sep 17, 2021 and Oct 7, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT SHE CANNOT SEE STILL EVEN AFTER A YEAR OF INTRAOCULAR LENS (IOL) IMPLANTATION. SHE FELT VISION WAS WORSE SINCE HAVING LENS IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SHE HAD ISSUES READING AND SEEING STREET SIGNS, HAD A STITCH IN ONE EYE WHICH WAS REMOVED POST OPERATIVE VISIT AND WOULD REQUIRE LASER FOR BOTH EYES DUE TO SECONDARY CATARACT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

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

  MAUDE report 15564350 ↗
• MalfunctionApr 13, 2022Crack; Crack

  A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION RIGHT AFTER INSERTION OF THE LENS IN THE CAPSULAR BAG A CRACK ON THE PARACENTRAL AREA OF THE OPTIC WAS NOTICED. ONE AND A HALF WEEKS POST OPERATIVELY THE PATIENT WAS 20/20 AND J1 UNCORRECTED. NO GLARE NOTICED.

  Patient problems: Insufficient Information

  MAUDE report 14103850 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE PATIENT CANNOT TOLERATE NIGHT VISION. ADDITIONAL INFORMATION REQUESTED, RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE 20 MONTHS FOLLOWING THE INITIAL PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 12487556 ↗