AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652418805), received between Aug 11, 2021 and Oct 5, 2021 — classified as 3 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 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.

• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD BLURRED VISION AND GLARE. THE LENS WAS EXPLANTED AFTER ONE MONTH FOLLOWING THE IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS GIVEN AS SIGNIFICANT ASTHENOPIA. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, NO NEW INFORMATION HAS BEEN RECEIVED.

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

  MAUDE report 12579286 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT SHE DID NOT HAVE CLEAR DISTANCE VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION. DRY EYE THERAPY WAS INITIATED AND PHOTOREFRACTIVE KERATECTOMY WAS PERFORMED TO IMPROVE DISTANCE VISION. DURING THE HEALING PROCESS, THE LEFT EYE DEVELOPED SHINGLES. THE CONSUMER INDICATED THAT SHE IS EXPERIENCING BALANCE ISSUES AND UNABLE TO SEE WELL ENOUGH TO DRIVE. SHE ALSO NOTED THAT THE EYE IS STILL HEALING. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT WILL REPRESENT THE LEFT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Viral Infection; Visual Impairment

  MAUDE report 12445419 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE IOL WAS EXCHANGED FOR A DIFFERENT IOL APPROXIMATELY AFTER 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12308052 ↗