ACRYSOF® SN60WF (REF SN60WF.100)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380655095614), received between Nov 15, 2021 and Dec 19, 2025 — classified as 3 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
Most reported problems
Device problems
- Defective Device1
- Device Contamination with Chemical or Other Material1
- Failure to Deliver1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK IN CARTRIDGE WHILE INSERTING. SURGEON ASKED TO REPLACE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23849036 ↗MalfunctionFeb 23, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PROCEDURE WAS ABLE TO BE COMPLETED ABSOLUTELY NORMALLY WITHOUT COMPLICATION. THERE ARE SEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR SIX OF SEVEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16428442 ↗MalfunctionNov 15, 2021Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12811488 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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