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ACRYSOF® SN60AT (REF SN60AT.245)Recalls & reported problems

Alcon Laboratories, Inc. · AcrySof(R) Natural SINGLE-PIECE ACRYLICFOLDABLE IOL, UV WITH BLUE LIGHT FILTER,POSTERIOR CHAMBER LENS (IOL/PC), 13.0mm LENGTH,6.0mm BICONVEX OPTIC, PLANAR HAPTICS. · Class 3 · Implant

All models of ACRYSOF (353)

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

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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380650130396), received between Oct 29, 2021 and Dec 31, 2025 — classified as 3 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Crack1
  • Defective Device1
  • Product Quality Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Insufficient Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 31, 2025Product Quality Problem; Product Quality Problem

    A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 23933861 ↗
  • MalfunctionNov 8, 2021Defective Device; Defective Device

    A HEALTHCARE PROFESSIONAL REPORTED A DEFECTIVE INTRAOCULAR LENS. EVENT DETAILS AND PATIENT INVOLVEMENT ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12770951 ↗
  • MalfunctionOct 29, 2021Crack; Crack

    A HEALTH PROFESSIONAL REPORTED THAT THREE (3) PATIENTS EXPERIENCED A CRACK IN THE IMPLANTED INTRAOCULAR LENS (IOL) IMPLANT AFTER A PROCEDURE. THE HEALTHCARE PROFESSIONAL STATED THEY CHECKED THE LENS PRIOR TO IMPLANTATION AND THERE WERE NO VISIBLE CRACKS. THIS RECORD IS FOR THE FIRST PATIENT ON THIS DATE OF EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING ALL SURGERIES WERE COMPLETED AND THE IOLS REMAIN IMPLANTED SO FAR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12722053 ↗

Other intraocular lens devices

All intraocular lens devices →

Sources and updates

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