AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652415569), received between Mar 1, 2021 and Oct 31, 2022 — classified as 3 injuries, 2 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE WITH A REASON OF BLURRY VISION WHILE READING/DRIVING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15697770 ↗
• InjuryJul 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS. THERE WAS AN ASYMMETRIC PROGRESSION ON (B)(6) 2020, IT WAS REPORTED THAT VISION TAKES HOUR TO FOCUS IN AM AND STRUGGLING TO SEE ROAD SIGNS, COMPLAINING OF FLOATERS AND THE LENS MOVED FROM 66 TO 70 DEGREES. ONE MONTH LATER THE VISION WAS DOING WELL, BUT PAIN ONCE IN A WHILE. AT 3 MONTHS CHECK, PATIENT WAS DISAPPOINTED AND STILL HAD FLOATERS AND A SHADOW ON RIGHT SIDE OF VISION. THERE WAS A MILD CAPSULAR BAG SYNDROME AND TRACE OF POSTERIOR CAPSULE OPACIFICATION. SAW THREE WEEKS LATER RIGHT EYE WAS NOT FOCUSING AND WAS UNABLE TO SEE UP CLOSE AT ALL, COMPLAINS OF FLOATERS AS WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Eye Pain; Visual Impairment; Vitreous Floaters

  MAUDE report 12111421 ↗
• InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER THE INITIAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PATIENT COMPLAINED OF "GLARE" AND A CLINICAL REASON OF "GLARE". THIS REQUIRED THE REMOVAL OF THE IOL IN A SECONDARY SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 11609927 ↗
• MalfunctionMar 22, 2021Crack; Crack

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION, A SMALL "CRACK" WAS OBSERVED IN THE PERIPHERY. THE IOL WAS CUT, REMOVED AND REPLACED WITH THE SAME MODEL AND POWER. THE IOL WAS DAMAGED DURING THE REMOVAL PROCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541892 ↗
• MalfunctionMar 1, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  A MATERIAL MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS "UNFOLDED WRONG". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11396373 ↗