AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30.200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652389976), received between May 23, 2022 and Dec 29, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Break; Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY THE LENS CAME OUT OF THE CARTRIDGE WITH ONE HAPTIC BROKEN. THE PHYSICIAN WAS UNABLE TO IMPLANT THE DAMAGED IOL WHICH HAD TO BE REMOVED INTO TWO PARTS. THE PATIENT WAS WAITING FOR ANOTHER LENS IMPLANTATION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 23908256 ↗
• MalfunctionJul 5, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT VISION ON THE OPERATED EYE HAD 6/15 WITH HIGH ASTIGMATISM. DOCTOR PLANS TO REMOVE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 19679724 ↗
• InjuryJun 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION HAD REGRESSED, GLISTENING'S DEVELOPED, LENS WERE STUCK TO THE CAPSULE IN BOTH EYES DURING SURGERY AND VIRTUOUS STRANDS AROUND THE INTRAOCULAR LENS. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 17076555 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE VISION NOT AS EXPECTED. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 16688523 ↗
• InjuryNov 2, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE IMPLANTATION OF INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED HALOS AND GLARES AT NIGHT THAT ARE SO BAD AND TRAFFIC SIGNAGE WAS BLURRY. THE PATIENT COULD NOT READ SIGNS UNTIL NEAR. THE OPTOMETRIST TOLD THAT THE LENS SHIFTED AFTER SURGERY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND PATIENT HAD RIM AND PULSES AT THE CORNER OF THE EYE WHEN LOOKED TO LEFT AND SIGNS ARE HARD TO MAKE OUT UNTIL RIGHT UNDER THEM. THE PATIENT DO NOT DRIVE AT NIGHT AS SHE SEES GLARES AND HALOS AND BLURRY SIGNS AT NIGHT, BUT TO A LESSER DEGREE IN THE DAYTIME. THE OPHTHALMOLOGIST DID A PINHOLE TEST WHICH CLEARED UP THE DISTANCE BLURRINESS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15713506 ↗
• InjuryNov 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE IMPLANTATION OF INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED HALOS AND GLARES AT NIGHT THAT ARE SO BAD AND TRAFFIC SIGNAGE WAS BLURRY. THE PATIENT COULD NOT READ SIGNS UNTIL NEAR. THE OPTOMETRIST TOLD THAT THE LEFT LENS SHIFTED AFTER SURGERY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND PATIENT HAD RIM AND PULSES AT THE CORNER OF THE EYE WHEN LOOKED TO LEFT AND SIGNS ARE HARD TO MAKE OUT UNTIL RIGHT UNDER THEM. THE PATIENT DO NOT DRIVE AT NIGHT AS SHE SEES GLARES AND HALOS AND BLURRY SIGNS AT NIGHT, BUT TO A LESSER DEGREE IN THE DAYTIME. THE OPHTHALMOLOGIST DID A PINHOLE TEST WHICH CLEARED UP THE DISTANCE BLURRINESS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15713223 ↗
• MalfunctionMay 23, 2022Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED AND REMOVED DUE TO FAULTY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14469968 ↗