ACRYSOF® SA60WF (REF SA60WF.165)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) ASPHERIC IOL, SINGLE-PIECE ACRYLICFOLDABLE POSTERIOR CHAMBER LENS,UV-ABSORBING, 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
- 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 00380652332590), received between Jul 14, 2022 and Feb 12, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material3
- Break1
- Device Damaged Prior to Use1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Device Damaged Prior to Use; Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE DEFECT WAS DISCOVERED WHEN THE PACKAGE WAS OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24329629 ↗MalfunctionJun 26, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BEFORE PROCEDURE IT WAS NOTED SCRATCH ON THE ENTIRE OPTICAL LENS. THERE WAS NO PATIENT CONTACT AND IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE SCRATCH WAS NOTICED WHILE LOADING THE LENS INTO THE CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22335343 ↗MalfunctionJan 21, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF HAPTIC MISSING WHICH WAS NOTED BEFORE SURGERY. ADDITIONAL INFORMATION RECEIVED STATING THAT LEADING HAPTIC WAS MISSING. THE PROCEDURE COMPLETED BY USING UNSPECIFIED REPLACEMENT IOL.
Patient problems: Insufficient Information
MAUDE report 21196015 ↗MalfunctionNov 10, 2023Scratched Material; Scratched Material
AN OTHER HEALTH CARE PROFESSIONAL REPORTED SEEING SOME IMPERFECTION ON THE INTRAOCULAR LENS (IOL) DURING IMPLANTATION, WHICH THEY DESCRIBED AS LIGHT SCRATCH OR DAMAGE. THERE WAS A BUMP IN THE LENS ON THE SIDE, WHICH WAS NOT DUE TO FOLDING BUT SOMETHING THAT WAS IN THE LENS. THE LENS REMAINS IMPLANTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18108862 ↗MalfunctionJul 14, 2022Scratched Material; Scratched Material
A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED A SCRATCH ON THE IOL OPTICS AFTER IMPLANTING THE LENS INTO THE PATIENT EYE. THE IOL WAS REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15016120 ↗
Other intraocular lens devices
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- 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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