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AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.135)Recalls & reported problems

Alcon Laboratories, Inc. · AcrySof® IQ PanOptix® Toric Trifocal intraocular lenses (IOLs) are ultraviolet absorbing foldable multifocal IOLs · Class 3 · Implant

All models of AcrySof IQ PanOptix Toric UV IOL (120)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652418577), received between Jul 8, 2021 and Jul 8, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Appropriate Device Problem Term/Code Not Available1
  • Failure to Unfold or Unwrap1

Patient problems

  • Blurred Vision2
  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1
  • Visual Impairment1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 8, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

    A NON HEALTHCARE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE OPTIC OF THE LENS WOULD NOT UNFOLD. THERE WAS PATIENT CONTACT. SURGERY WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING DURING SURGERY AFTER INSERTION LENS HAPTICS WOULD NOT UNFOLD AND STUCK TO LENS. THE LENS WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE ORIGINALLY SCHEDULED PROCEDURE WAS COMPLETED THE SAME DAY. PATIENT RECEIVED A REPLACEMENT LENS. THERE WAS NO PATIENT HARM. PATIENT¿S ISSUES HAVE BEEN RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14957826 ↗
  • InjuryJun 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    A FACILITY REPRESENTATIVE THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXPLANTED DUE TO PATIENT WAS UNABLE TO ADAPT TO LENS. THE IOL WAS EXCHANGED FOR ANOTHER COMPANY MONOFOCAL LENS. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 14673464 ↗
  • InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A MATERIAL MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND THE CLINICAL REASON WAS RESIDUAL MYOPIA. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT HERE WAS NO PATIENT HARM.

    Patient problems: Blurred Vision; Visual Impairment

    MAUDE report 13174237 ↗
  • InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION WITH BEST CORRECTED VISUAL ACUITY OF 20/50. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL APPROXIMATELY 6 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

    Patient problems: Blurred Vision

    MAUDE report 12133146 ↗

Other Lens, multifocal intraocular devices

All Lens, multifocal intraocular devices →

Sources and updates

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