ACRYSOF® SN60AT (REF SN60AT.230)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) Natural SINGLE-PIECE ACRYLICFOLDABLE IOL, UV WITH BLUE LIGHT FILTER,POSTERIOR CHAMBER LENS (IOL/PC), 13.0mm LENGTH,6.0mm 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380650130365), received between Jun 6, 2024 and May 30, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Material Opacification1
- Product Quality Problem1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2025Product Quality Problem; Product Quality Problem
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE SURGEON NOTICED THE INTRAOCULAR LENS(IOL) WAS DEFECTIVE AFTER IMPLANTATION. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH THE COMPANY LENS OF SAME DIOPTER. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22112574 ↗MalfunctionMar 24, 2025Material Opacification; Material Opacification
A SURGEON REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAD A COATING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SURGEON COULD SEE THE IRREGULAR COATING NEXT TO THE REFLECTION OF THE SLIT LAMP AND THE EXAMINATION ROOM, PRIMARILY ON THE LEFT IN THE LIGHT CONE, BUT IT WAS PRESENT EVERYWHERE. THE LENS WAS NOT EXPLANTED, IN SURGEON OPINION THERE WAS A COATING ON THE LENS THAT PERSISTS AND REPRESENTS A QUALITY DEFECT. IT WAS VISIBLE EVEN BEFORE CONTACT WITH VISCOELASTIC.
Patient problems: Insufficient Information
MAUDE report 21677038 ↗MalfunctionJun 6, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19476406 ↗
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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