AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT50 (REF TFNT50U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652416597), received between Jun 13, 2022 and Jan 17, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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 18, 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.

• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT STILL SEE QUADRUPLE FROM THE EYE AND PATIENT SEES 2 LETTERS VERY CLEAR ONE NEXT TO THE OTHER (NOT OVERLAPPED) WHEN LOOKS AT A LETTER AND ANOTHER 2 LETTERS MORE SOFT OR TRANSPARENT OVERLAPPED. THE PATIENT WAS CONSULTED WITH PHYSICIAN AND PHYSICIAN WAS DONE UNSPECIFIED EXAMINATIONS WITH UNSPECIFIED MACHINES AND GAVE A DEVICE TO PLACE A UNSPECIFIED DROP 2 TIMES A WEEK. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS NOT ABLE TO READ AND COULD NOT SEE PROPERLY. THE DOCTOR GAVE PILOCARPINE DROPS. THE TESTS THAT PERFORMED WERE NORMAL BUT THE REFRACTION WAS INCREASED AND DECIDED NOT TO GIVE DROPS. THE DOCTOR SUGGESTED THE PATIENT TO USE POWER CONTACT LENS WHICH WAS HELPFUL. THE PATIENT WANTS REFRACTION STABILITY.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances

  MAUDE report 18525256 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS NOT ABLE TO READ AND COULD NOT SEE PROPERLY. THE DOCTOR GAVE PILOCARPINE DROPS. THE TESTS THAT PERFORMED WERE NORMAL BUT THE REFRACTION WAS INCREASED AND DECIDED NOT TO GIVE DROPS. THE DOCTOR SUGGESTED THE PATIENT TO USE POWER CONTACT LENS WHICH WAS HELPFUL. THE PATIENT WANTS REFRACTION STABILITY.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances

  MAUDE report 17711723 ↗
• MalfunctionJun 13, 2022Failure to Align; Failure to Align

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, POST OPERATION 2 WEEKS LENS WAS HAS BEEN ROTATED. DOCTOR MENTIONED LATER ON GLASSES OR CONTACTS MAY HELP OR MAYBE LASIK, BUT NOT UNTIL 6 MONTHS AFTER SURGERY, AND HAS NO PLANS FOR EXPLANT. THIS IS CAUSING HER TO HAVE EYE STRAIN. DURING SURGERY HE TRIED FOR 40 MINUTES TO GET THE LENS TURNED TO THE CORRECT POSITION AND WAS NOT ABLE TO GET IT TO TURN. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT DURING CATARACT SURGERY HE TRIED FOR 40 MINUTES TO GET THE LENS TURNED TO THE CORRECT POSITION AND WAS NOT ABLE TO GET IT TO TURN. HE SAYS THAT HE HAS NEVER HAD THIS TO HAPPEN BEFORE AND DOESN¿T KNOW WHY. IT¿S BEEN 10 DAYS AND MY VISION HAS NOT CLEARED UP. YESTERDAY HE INFORMED ME THAT THE LENS CAN¿T BE REPLACED AND IT MAY OR MAY NOT CLEAR UP.

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

  MAUDE report 14674457 ↗