ACRYSOF® SN60WF (REF SN60WF.085)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 00380655095584), received between Jun 19, 2024 and Dec 30, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Scratched Material1
Patient problems
- Insufficient Information2
- Blurred Vision1
- Dizziness1
- Dry Eye(s)1
- Nausea1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS FOUND TO HAVE BROKEN HAPTIC.
Patient problems: Insufficient Information
MAUDE report 23923155 ↗MalfunctionMay 26, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE DOCTOR OBSERVED A SCRATCH AT THE LENS OPTIC UNDER MICROSCOPE AND WORRIED IT WILL AFFECT PATIENT¿S VISION. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THE SURGERY COMPLETED BY USING ANOTHER SAME MODEL SAME POWER LENS.
Patient problems: Insufficient Information
MAUDE report 22084682 ↗InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE THE PATIENT EXPERIENCED DIZZINESS, NAUSEA, BLURRY VISION DUE TO EXTREME EYE DIFFERENCE. DISORIENTED FOR SIX MONTHS, WARM COLORS APPEARED MUTED AND TROUBLE WALKING. THE PATIENT HAD A YAG CAPSULOTOMY TO TREAT HER POSTERIOR CAPSULAR OPACIFICATION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Dizziness; Dry Eye(s); Nausea; Visual Disturbances
MAUDE report 19565585 ↗
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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