ACRYSOF® SN60WF (REF SN60WF.160)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
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380655093115), received between Apr 5, 2021 and Jan 9, 2026 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Crack” (3 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
- Crack3
- Material Split, Cut or Torn3
- Defective Device1
- Difficult to Insert1
- Entrapment of Device1
- Material Opacification1
- Scratched Material1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions3
- Visual Disturbances1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2026Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, LENS OPTIC WAS BROKEN OR TORN DURING LOADING. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019078 ↗MalfunctionJun 5, 2025Material Opacification; Material Opacification
A CONSUMER REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) IMPLANT WAS DONE OVER 15 YEARS AGO, AND THERE APPEARS TO BE SOME CLOUDINESS ON THE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22151080 ↗MalfunctionApr 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS FAULTY, IT HAD A DEEP CRACK THROUGH THE CENTRE.
Patient problems: Insufficient Information
MAUDE report 21864276 ↗MalfunctionMay 29, 2023Crack; Entrapment of Device; Crack; Entrapment of Device
A HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE IT WAS NOTED THAT THE LENS WAS STUCK IN THE INCISION AS PATIENT WAS MOVED. ALSO NOTED THERE WAS A SMALL CRACK ON THE OPTIC. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 17016873 ↗MalfunctionApr 14, 2023Crack; Crack
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A CRACK. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16742608 ↗MalfunctionDec 6, 2022Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT LOADING ISSUE, TORE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15922879 ↗InjuryMay 12, 2022Defective Device; Defective Device
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEFT EYE IMPLANT HAVE A DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT WHEN PATIENT LOOKING AT ANY STRAIGHT VERTICAL EDGE, THERE ARE DIAGONAL LINES THAT EFFECTING THE EDGE, THE LINES ARE SYMMETRICAL AND ONLY TRANSVERSE ONLY ON VERTICAL EDGES. THE PATIENT SEE ENLARGED VERSION OF IMAGES AS COMPARED TO RIGHT EYE. ESTIMATED ABOUT A 15 - 20 % INCREASE IN SIZE OF THE IMAGE. BEFORE THE SURGERY BOTH THE LEFT AND THE RIGHT EYE WERE IDENTICAL BUT AFTER SURGERY PATIENT NOT ABLE TO FOCUS PROPERLY DUE TO THE DIFFERENT IMAGE SIZES. FOR ANY CLOSE UP WORK, E.G. WORKING ON COMPUTER, PATIENT NEED TO CLOSE ONE EYE AS HE SEE DUAL IMBALANCED IMAGES WITH BOTH EYES OPEN. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Visual Disturbances
MAUDE report 14367189 ↗MalfunctionFeb 25, 2022Crack; Crack
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, OPERATION ROOM TEMPERATURE WAS DROPPED TO 50 DEGREES FAHRENHEIT. DURING PROCEDURE LENS HAD CRACKED AND LENS HAD TO BE CUT OUT, PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13598890 ↗MalfunctionApr 5, 2021Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOTED TO HAVE A SMUDGE. THERE WAS NO HARM TO THE PATIENT AND ANOTHER LENS WAS IMPLANTED INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11613885 ↗
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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