ACRYSOF® SA60WF (REF SA60WF.200)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
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652332668), received between Mar 15, 2021 and Apr 9, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device2
- Device Contamination with Chemical or Other Material2
- Scratched Material2
- Break1
- Contamination1
- Crack1
- Device Damaged by Another Device1
- Failure to Eject1
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026Particulates; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT HAIR ON THE LENS AND THE HAPTIC WAS BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS A HAIR ON THE IOL, AND ALSO THAT THE HAPTIC OF THE IOL WAS SLIGHTLY BENT. THIS WAS DISCOVERED BEFORE IMPLANTATION, NAMELY WHEN THEY WENT TO CHECK THE IOL BEFORE FOLDING IT. THER WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED WITH COMPANY SIMILAR MODEL LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24837977 ↗MalfunctionApr 23, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS DAMAGED BY AN UNSPECIFIED INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21888241 ↗MalfunctionApr 21, 2023Crack; Crack
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS CRACKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16782707 ↗MalfunctionMar 28, 2023Break; Failure to Eject; Break; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INSERTION OF THE INTRAOCULAR LENS (IOL), THE LENS WAS STUCK IN THE CARTRIDGE AND LEADING HAPTIC WAS BROKEN. THE SURGEON DECIDED TO CHANGE THE LENS AND COMPLETED THE PROCEDURE WITH ANOTHER MODEL LENS DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16626026 ↗MalfunctionJan 11, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16136071 ↗MalfunctionSep 30, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AN UNIDENTIFIED FIBER APPEARS IN THE PATIENT¿S EYE AFTER IMPLANTING A COMPANY LENS. THIS FIBER APPEARED TO BE STIFF AND NOT VERY PLIABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15520559 ↗MalfunctionJun 23, 2022Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED VIA IOL REPLY CARD DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14786418 ↗MalfunctionJan 28, 2022Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOTED DAMAGED. THE LENS HAS BEEN WASTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13385117 ↗MalfunctionOct 11, 2021Contamination; Contamination
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION PROCEDURE, AN UGLY STRING OF A LENS FOR LEG ATTACHMENT HAS BEEN OBSERVED. THE LENS IS STILL IN PATIENT'S EYE. NO INFORMATION EXPECTED AS INITIAL REPORTER IS UNWILLING TO PROVIDE FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12605159 ↗MalfunctionApr 12, 2021Scratched Material; Scratched Material
AN INTRAOCULAR LENS (IOL) REPLY CARD WAS RECEIVED FROM A CUSTOMER STATING THAT DURING AN IOL IMPLANT PROCEDURE, THE LENS WAS SCRATCHED, NOT IMPLANTED. THERE WAS NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED
Patient problems: Insufficient Information
MAUDE report 11649259 ↗MalfunctionMar 15, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A HEALTHCARE PROFESSIONAL REPORTED PLASTIC MATERIAL EMBEDDED IN THE OPTIC OF THE INTRAOCULAR LENS (IOL). THE IOL REMAINS IMPLANTED. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11485701 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page