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ACRYSOF® SN60WF (REF SN60WF.270)Recalls & reported problems

Alcon Laboratories, Inc. · AcrySof(R) IQ ASPHERIC Natural IOL, SINGLE-PIECE ACRYLIC FOLDABLE PCL, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC 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
4
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380655095744), received between May 11, 2021 and Dec 29, 2023 — classified as 1 injury, 3 malfunctions.

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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 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: 0 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

  • Defective Component1
  • Failure to Advance1
  • Material Split, Cut or Torn1
  • Particulates1

Patient problems

  • Insufficient Information2
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionDec 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS CRACKED DURING INSERTION AND NEEDED TO BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 18417490 ↗
  • MalfunctionSep 15, 2022Failure to Advance; Failure to Advance

    A NON HEALTH PROFESSIONAL REPORTED THAT THE CARTRIDGE DID NOT ADVANCE AND THERE WAS A PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH BACK UP LENS. ADDITIONAL INFORMATION WILL BE REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 15427205 ↗
  • InjuryJun 6, 2022Defective Component; Defective Component

    A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC ISSUE WAS FOUND. TH OPTIC DID NOT SLIDE THROUGH 2.4MM WOUND. THE INCISION WAS ENLARGED AND NEW LENS USED DURING INITIAL PROCEDURE. NO INJURY TO PATIENT WAS REPORTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14604132 ↗
  • MalfunctionMay 11, 2021Particulates; Particulates

    A CUSTOMER REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) A SMALL METALLIC FRAGMENT ON THE ANTERIOR SURFACE OF ONE OF THE LENS WAS NOTED. THE FOREIGN BODY WAS REMOVED DURING THE SAME PROCEDURE AND THE SURGERY WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11805405 ↗

Other intraocular lens devices

All intraocular lens devices →

Sources and updates

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