ACRYSOF® SN60WF (REF SN60WF.130)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 00380655095676), received between Sep 1, 2021 and Mar 25, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged by Another Device1
- Material Opacification1
Patient problems
- Blurred Vision1
- Capsular Bag Tear1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Device Damaged by Another Device; Device Damaged by Another Device
A COMPLAINT WAS RECEIVED FROM THE CHINA LOCAL HA SYSTEM REGARDING DURING CATARACT PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATION SURGERY, IT WAS FOUND THAT THE OPTICAL AREA OF THE LENS WAS DAMAGED DURING IMPLANTATION IN THE PUSHER, AND IT WAS PRELIMINARILY JUDGED THAT IT MAY BE DUE TO PRODUCT QUALITY ISSUES. THE PROCEDURE WAS COMPLETED WITH NEW LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21687875 ↗MalfunctionJan 8, 2024Material Opacification; Material Opacification
A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, NOTICED IOL¿S APPEAR ON THE SLIT LAMP TO BE OPACIFYING CAUSING VISUAL ACUITY LOSS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 18464095 ↗InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A MATERIALS MANAGEMENT REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A TORN CAPSULE WAS DISCOVERED. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THERE WAS PATIENT CONTACT AND THAT THE PROCEDURE WAS COMPLETED. THE PATIENT¿S ISSUES HAVE RESOLVED.
Patient problems: Capsular Bag Tear
MAUDE report 12406624 ↗
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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