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ACRYSOF® SN60WF (REF SN60WF.275)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 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380655095751), received between Jun 17, 2022 and Apr 17, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 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: 1 reportsApr 2026: 1 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

  • Adverse Event Without Identified Device or Use Problem1
  • Defective Device1
  • Failure to Unfold or Unwrap1
  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Capsular Bag Tear1
  • Visual Disturbances1

Recent adverse event reports

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

  • MalfunctionApr 17, 2026Material Split, Cut or Torn

    A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A SMALL CRACK ON IT. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED REPLACEMENT LENS AND THERE WAS NO DISCOMFORT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24911455 ↗
  • MalfunctionMar 16, 2026Failure to Unfold or Unwrap

    A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION OF LENS IT WAS NOTED THAT BOTH THE LENS HAPTICS WERE TIGHTLY ADHERED TO THE OPTIC AND COULD ONLY BE SEPARATED WITH DIFFICULT MANUAL MANIPULATION. THERE WAS A PATIENT CONTACT REPORTED. THE PATIENT UNDERGONE FOR UNSPECIFIED INTERVENTION. AS PER THE PHYSICIAN THERE WAS A UNSPECIFIED IMPACT TO THE PATIENT AND THE IMPACT WAS CONTINUED WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED PATIENT CURRENT CONDITION WAS GOOD. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 1 OF 5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24605825 ↗
  • InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF POSTERIOR CAPSULAR RAPTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Capsular Bag Tear

    MAUDE report 18893078 ↗
  • InjuryJun 17, 2022Defective Device; Defective Device

    A SURGEON REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS HAD A CENTRAL DEFECT. THREE WEEKS POST OPERATION PATIENT HAD VISUAL DISTURBANCE AND ALSO ARMD (AGE-RELATED MACULAR DEGENERATION). NO ADDITIONAL INFORMATION IS AVAILABLE ON THIS CASE AS OF YET. ADDITIONAL INFORMATION RECEIVED STATING SURGEON PLANS TO EXPLANT THE LENS IN FUTURE DUE TO A CENTRAL DEFECT.

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

    MAUDE report 14734477 ↗

Other intraocular lens devices

All intraocular lens devices →

Sources and updates

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