AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652414937), received between Jun 22, 2021 and Jun 14, 2022 — 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. How this data works · Data updated Oct 13, 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.

• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CERTIFIED OPHTHALMIC ASSISTANT REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION LOSS WHICH WAS ONGOING, POOR VISION ACROSS ROOM, CLOUDINESS, BLURRY VISION AND WHITE OUT ON ALL DIGITAL SCREENS, GLARE WHICH WAS DAY AND NIGHT AND HEADACHES. DUE TO THE REPORTED SYMPTOMS, THE LENS WAS EXPLANTED APPROXIMATELY A YEAR AFTER IOL IMPLANTATION. THE PHYSICIAN STATES THAT THE PATIENT WAS INTOLERANT TO THE SUSPECT PRODUCT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Headache; Visual Disturbances; Visual Impairment

  MAUDE report 14685830 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION IN THE RIGHT EYE THE PATIENT HAD EXPERIENCED BLURRY VISION AND COULD NOT SEE WELL ON NEAR VISION LIKE READING A BOOK OR PHONE SCREEN. THE RIGHT EYE HAS A SPOT THAT APPEARS ON INNER SIDE OF THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT WAS PRESCRIBED WITH GLASSES. THE POWER HAS GONE UP FROM 1.25 TO 3.25 FOR THE READING GLASSES WHICH WORK ONLY FOR A WHILE BEFORE THE EYES START TO HURT. THE PATIENT COULD NOT SEE SMALL PRINT AND THE VISION HAS GONE FROM BAD TO WORSE. THERE ARE TWO REPORTS ASSOCIATED WITH THIS FILE, THIS REPORT IS FOR THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 13949793 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT CANNOT SEE WELL ON NEAR VISION AND CAN'T READ A REGULAR SIZE LETTER BOOK, OR MAGAZINE. I CAN'T SEE MY PHONE SCREEN CLEAR. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT CANNOT SEE SMALL PRINT AND PRESCRIBED WITH GLASSES. THE POWER HAS GONE FROM 1.25 TO 3.25 FOR READING GLASSES AND THEY WORK FOR ONLY A WHILE BEFORE EYES START HURTING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 13936865 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO ADAPT TO THE MULTIFOCAL IOL AND USING READERS FOR CLOSE UP ACTIVITIES. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 12244801 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRY VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE 19 MONTHS FOLLOWING THE INITIAL IMPLANTATION. ADDITIONAL INFORMATION WAS RECEIVED STATES THAT THE SURGEONS OPINION THERE WAS MORE POWER LEFT IN OS PRESCRIPTION THAN ORIGINALLY PLANNED FOR SO IT WAS CAUSING BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 12041379 ↗