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ACRYSOF® SN60WF (REF SN60WF.155)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
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380655095720), received between Sep 30, 2021 and Dec 15, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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

  • Contamination1
  • Device Dislodged or Dislocated1
  • Failure to Unfold or Unwrap1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Blurred Vision1

Recent adverse event reports

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

  • MalfunctionDec 15, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

    A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL UNFOLDED PRIOR TO ENTERING EYE. THERE WAS A PATIENT CONTACT BUT NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15986169 ↗
  • InjuryMar 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    A FACILITY REPRESENTATIVE REPORTED THAT, FOLLOWING INTRAOCULAR LENS EXPLANT PROCEDURE, THE PATIENT HAD FOGGY VISION AND DISLOCATED LENS POSTERIOR. THE LENS WAS EXPLANTED IN SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT, THE PATIENT WAS HAVING PRE-EXISTING OCULAR CONDITIONS OF GLAUCOMA, POSTERIOR VITREOUS DETACHMENT, LATTICE DEGENERATION, PSEUDOPHAKIA, POSTERIOR CAPSULAR OPASITY AND MYOPIC DEGENERATION. THERE WAS NO PATIENT HARM INVOLVED WITH THE IOL IMPLANTATION PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

    Patient problems: Blurred Vision

    MAUDE report 13904763 ↗
  • MalfunctionSep 30, 2021Contamination; Contamination

    A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PHYSICIAN FOUND A FRAGMENT/FIBER IN THE ANTERIOR CHAMBER OF A PATIENT AFTER IOL INSERTION. PHYSICIAN HAD SAVED THE FIBER IN THE VIAL. ADDITIONAL INFORMATION WAS RECEIVED AND THE LENS WAS STILL IN PATIENT'S EYE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12554361 ↗

Other intraocular lens devices

All intraocular lens devices →

Sources and updates

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