ACRYSOF® SN60WF (REF SN60WF.145)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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380655095706), received between Nov 28, 2022 and Oct 21, 2025 — classified as 1 injury, 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
Most reported problems
Device problems
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Failure to Advance1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Blurred Vision1
- Dizziness1
- Headache1
- Insufficient Information1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS INSERTED INTO THE CARTRIDGE HOLDER AND INTENDED FOR USE. WHEN EXITING FROM THE HOLDER THE LOOP ORIENTED TO THE RIGHT INSTEAD TO THE LEFT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23347020 ↗InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, OUT OF FOCUS, DARK, OVER SENSITIVE TO LIGHT, EVERY DAY HEADACHES. ADDITIONAL INFORMATION HAS RECEIVED, PATIENT ALSO EXPERIENCED BLURRY VISION OF ALL DISTANCES. ADDITIONAL INFORMATION HAS RECEIVED, PATIENT EXPERIENCED DIZZINESS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Blurred Vision; Dizziness; Headache; Visual Disturbances; Visual Impairment
MAUDE report 19048918 ↗MalfunctionJan 2, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING INJECTION INTO THE EYE, THE LENS BROKE AT THE TIME OF IMPLANTATION AND THEN REMOVED. THE OPERATION WAS COMPLETED WITH THE HELP OF ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS IMPLANTED AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18423993 ↗MalfunctionOct 24, 2023Break; Failure to Advance; Break; Failure to Advance
A PURCHASER REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, LENS WAS STUCK IN CARTRIDGE AND THE HAPTIC BROKE DURING INSERTION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17994566 ↗MalfunctionNov 28, 2022Crack; Crack
A FACILITY REPRESENTATIVE REPORTED THAT, THE INTRAOCULAR LENS (IOL) WAS CRACKED AFTER IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15868173 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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