AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30U110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652415347), received between Apr 7, 2021 and Jul 2, 2021 — classified as 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A CONSUMER THAT HE WAS NOT HAPPY WITH THE LENS IMPLANT, AND HAS BEEN SUGGESTED TO REMOVE LENS AND INSERT A DIFFERENT LENS. PATIENT HAD A STEAMY, SMOKEY VISION OD. HE STATES SURGEON DID PRK TO HELP CLEAR IT UP WITH NO IMPROVEMENT. HE WAS THEN REFERRED TO RETINA SPECIALIST AND HAD A VITRECTOMY WITH NO IMPROVEMENT. HE IS BEING ADVISED NOW, HE LIKELY NEEDS AN IOL EXCHANGE. HE DOES NOT KNOW HIS SN NOR DOES HE KNOW THE DATE OF SURGERY. HE DID PROVIDE THE SURGEON NAME, AND FACILITY WHERE IT WAS DONE. ADDITIONAL INFORMATION REQUESTED.

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

  MAUDE report 12106765 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE IOL WAS REPLACED WITH A HALF A DIOPTER DIFFERENCE OF POWER AND A DIFFERENCE OF TORICITY STRENGTH.

  Patient problems: Blurred Vision

  MAUDE report 11628572 ↗