AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50 (REF TFAT50.190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652419741), received between Jun 18, 2021 and Mar 13, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2022Defective Device; Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THERE WAS A TEAR IN THE LENS AND THE LENS WAS NOT IMPLANTED AN REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PROCEDURE WAS COMPLETED WITH A BACK UP LENS ON THE SAME DAY. THERE WAS NO HAM TO THE PATIENT AND WAS NOT HOSPITALIZED FOR THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13751346 ↗
• InjuryOct 27, 2021Defective Component; Defective Component

  A HEALTH PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING THE POST OPERATION VISIT, DEFECT IN THE LENS HAPTIC WAS NOTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED REPORTING THE PATIENT HAD POST OPERATION VISUAL ISSUES, THE POSSIBLE LENS/HAPTIC ISSUE. THE IOL WAS EXCHANGED FOR ANOTHER LENS 7 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Visual Disturbances

  MAUDE report 12703224 ↗
• InjuryJul 27, 2021Malposition of Device; Malposition of Device

  A PHYSICIAN REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL ROTATED AND APPEARED TO BE OF WRONG POWER. REFRACTIVE OUTCOME WAS OFF. IOL PLACED AT 163 AND 2 WEEKS POST VISIT IT ROTATED TO 45 DEGREES. PATIENT REPORTS INITIALLY DECENT VISION BUT SLIGHTLY MYOPIC AND OVER A TWO WEEK PERIOD VISION DETERIORATED WITH HIGH ASTIGMATISM PRESENT ON REFRACTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12228029 ↗
• InjuryJun 18, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED POOR VISION QUALITY AND HALOS. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON GIVEN FOR THE EXPLANT WAS ¿DYSPHOTOPSIA, PIGMENT DEPOSITS ON ANTERIOR IOL.¿ ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 12023916 ↗