ACRYSOF® SN60AT (REF SN60AT.225)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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380650130358), received between Mar 11, 2021 and Jul 21, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Opacification” (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
- Material Opacification2
- Appropriate Device Problem Term/Code Not Available1
- Crack1
- Device Contamination with Chemical or Other Material1
- Material Deformation1
- Sharp Edges1
Patient problems
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2025Material Opacification; Material Opacification
A PHYSICIAN REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS HAD COATING ON THE IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS REMAINED IMPLANTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553583 ↗MalfunctionMay 13, 2025Material Deformation; Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT HAD IOLS WITH SIGNIFICANT GLISTENING'S THAT SEEM TO BE VISUALLY SIGNIFICANT. THE SYMPTOMS CONTINUED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Insufficient Information
MAUDE report 22011249 ↗MalfunctionNov 23, 2021Crack; Crack
A HEALTH PROFESSIONAL REPORTED THAT TWO PATIENTS EXPERIENCED A CRACK IN THE IMPLANTED INTRAOCULAR LENS (IOL) IMPLANT AFTER A PROCEDURE. THE HEALTHCARE PROFESSIONAL STATED THEY CHECKED THE LENS PRIOR TO IMPLANTATION AND THERE WERE NO VISIBLE CRACKS. THIS RECORD IS FOR THE FIRST PATIENT WITH THE EVENT OCCURRING IN THE RIGHT EYE ON THIS DATE OF EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT ALL SURGERIES WERE COMPLETED AND THE IOLS REMAIN IMPLANTED SO FAR.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12859495 ↗MalfunctionApr 8, 2021Material Opacification; Appropriate Device Problem Term/Code Not Available; Material Opacification; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT STATING THAT SHE WILL NOT DO AN ADDITIONAL EXAMINATION BECAUSE OF THE ADDITIONAL COSTS. SHE CONSULTED DR. (B)(6) JUST ONCE. THE IMPLANTATION WAS PERFORMED BY DR. (B)(6).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 11636218 ↗MalfunctionMar 11, 2021Device Contamination with Chemical or Other Material; Sharp Edges; Device Contamination with Chemical or Other Material; Sharp Edges
A PHYSICIAN REPORTED, THERE WAS A CUT EDGE WITH A "STRING" HANGING OFF WHERE HAPTIC COMES OFF THE OPTIC. IT SEEMED SHARP SO THE PHYSICIAN GRABBED IT AND PEELED IT OFF SMOOTHLY. THE SURGEON REPORTS THIS IS THE SECOND TIME THIS HAPPENED THE SAME DAY. ADDITIONAL INFORMATION IS REQUESTED. THERE ARE TWO RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE FIRST EVENT AND AN ADDITIONAL REPORT WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 11465568 ↗
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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