Skip to content

ACRYSOF® SN60WF (REF SN60WF.150)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
10
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380655095713), received between Jul 19, 2021 and Aug 22, 2025 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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: 1 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: 1 reportsJul 2025: 0 reportsAug 2025: 1 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

  • Adverse Event Without Identified Device or Use Problem4
  • Break2
  • Defective Device1
  • Device Dislodged or Dislocated1
  • Device Markings/Labelling Problem1
  • Failure to Advance1
  • Scratched Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Visual Disturbances3
  • Blurred Vision1
  • Halo1
  • Insufficient Information1
  • Visual Impairment1

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 22, 2025Break; Break

    A NURSE REPORTED THAT DURING SURGERY, THEY NOTICED THAT IDENTIFIED IOL HAPTIC AMPUTATION AFTER IMPLANTATION. THE LENS WAS CUT AND EXPLANTED, AND REPLACED WITH ANOTHER AVAILABLE LENS. PROCEDURE WAS COMPLETED ON THE SAME DAY. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22873969 ↗
  • MalfunctionJun 24, 2025Break; Break

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON REALIZED THAT THE HAPTIC WAS BROKEN BEFORE LOADING. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22313343 ↗
  • InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A CONSUMER REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY DISTANCES VISION. THE VISION WAS NOT SHARP AS BEFORE. THE PATIENT WAS NOT ABLE TO READ WORDS ON TV SCREENS OR PROJECTED SLIDES AND NOT ABLE TO PERCEIVE THE DEPTH OF SCARS ON UNEVEN PAVEMENTS WHILE WALKING. THE PATIENT WAS EXPERIENCING STAR LIKE INSTANCES , (SATURN) ROUNDISH BODIES SURROUNDED BY AN EQUATORIAL RING) , SPIKY BLOBS LIKE SAUCES. THE MEASURED AND RECOVERED VISUAL POWER WAS 10/10 ON LEFT EYE. BUT PATIENT PERCEPTION WAS INDIVIDUAL LETTERS OF ANY SIZE DON¿T APPEAR AS STRAIGHT SEGMENTS, BUT AS TWISTED (ZIGZAG) SEGMENTS. THE PATIENT HAD SHARPNESS ISSUE.

    Patient problems: Blurred Vision; Halo; Visual Disturbances

    MAUDE report 19219592 ↗
  • InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NURSE REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED AND THE PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 17540185 ↗
  • InjuryJul 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT COULD NOT SEE WELL DUE TO POOR LENS CENTRATION HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Visual Impairment

    MAUDE report 17332621 ↗
  • MalfunctionJul 12, 2023Scratched Material; Scratched Material

    A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION UPON IMPLANTING THE LENS INTO THE POUCH, THERE WERE OBVIOUS SCRATCHES IN THE LOCATION OF THE MIDDLE OPTICAL ZONE. IN ORDER TO ENSURE THE PATIENT¿S POSTOPERATIVE VISION IS NORMAL, THE PHYSICIAN CHANGED TO A NEW LENS. SUBSEQUENT SUCCESSFUL IMPLANTATION INTO THE PATIENT¿S EYES DID NOT HAVE ANY EFFECT ON THE PATIENT¿S HEALTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17309958 ↗
  • InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED STARBURSTS WHEN DRIVING AT NIGHT AND IS STARTING TO NOTICE IT WHILE DRIVING DURING THE DAY. A YAG WAS PERFORMED IN EACH EYE AND THERE WAS NO IMPROVEMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE RIGHT EYE.

    Patient problems: Visual Disturbances

    MAUDE report 15994908 ↗
  • InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED STARBURSTS WHEN DRIVING AT NIGHT AND IS STARTING TO NOTICE IT WHILE DRIVING DURING THE DAY. A YAG WAS PERFORMED IN EACH EYE AND THERE WAS NO IMPROVEMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE.

    Patient problems: Visual Disturbances

    MAUDE report 15994905 ↗
  • InjuryNov 22, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER, WHO REPORTED THAT THE PATIENT'S LEFT EYE WAS AFFECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12850556 ↗
  • MalfunctionJul 19, 2021Failure to Advance; Defective Device; Failure to Advance; Defective Device

    IT WAS REPORTED BY NON-HEALTHCARE PROFESSIONAL, THAT DOCTOR AND STAFF FELT THAT INTRAOCULAR LENS WAS DEFECTIVE AS TEXTURE OF THE IOL FELT STIFF, NOT SOFT AND WOULD NOT DEPLOY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12187835 ↗

Other intraocular lens devices

All intraocular lens devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page