ACRYSOF® SA60WF (REF SA60WF.195)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
- 15
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380652332651), received between Mar 26, 2021 and May 6, 2026 — classified as 1 injury, 14 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device3
- Scratched Material3
- Device Contamination with Chemical or Other Material2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Defective Component1
- Device Damaged by Another Device1
- Failure to Eject1
Patient problems
- Insufficient Information7
- No Clinical Signs, Symptoms or Conditions6
- Blurred Vision1
- Foreign Body In Patient1
- Visual Impairment1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Material Split, Cut or Torn
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED TEARS. THE LENS WAS CAREFULLY INSPECTED BEFORE LOADING AND NO TEARS WAS OBSERVED. AFTER THE LENS UNFOLDED IN THE PATIENT EYE A SIGNIFICANT TEAR WAS SEEN. THE TEARS MUST HAVE OCCURRED IN CONNECTION WITH THE LOADING OF THE LENSES. DURING LOADING, THE UTMOST CARE WAS TAKEN, THE OPTIC WAS NOT TOUCHED, AND ALL CONTACT WAS MADE ONLY WITH THE HAPTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS LEFT IN PATIENT EYE.
Patient problems: Insufficient Information
MAUDE report 25093612 ↗MalfunctionSep 19, 2025Material Twisted/Bent; Material Twisted/Bent
A PHARMACIST REPORTED WITH A DESCRIPTION, HAPTIC OF THE LENS WAS DAMAGED. THE LENS WAS REPLACED BEFORE IMPLANTATION. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095310 ↗MalfunctionJul 4, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE THERE WAS A SCRATCH MARK IN THE OPTIC OF THE LENS. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE SURGEON BELIEVES THAT THE INJECTOR PLUNGER MIGHT HAVE CAUSED THE SCRATCH IN THE POSTERIOR SIDE OF THE LENS.
Patient problems: Insufficient Information
MAUDE report 22402890 ↗MalfunctionMay 9, 2025Break; Break
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21996427 ↗MalfunctionNov 11, 2024Defective Component; Defective Component
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING LOADED THE HAPTIC GOT STUCK. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20653756 ↗MalfunctionApr 19, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WITH A SCRATCH ON THE OPTICS. HAD TO BE REMOVED USING A LENS CUTTER AND THEN IMPLANTED A NEW LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19142864 ↗MalfunctionMay 8, 2023Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS WAS DEFECTIVE.ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16886237 ↗MalfunctionMay 10, 2022Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A DEFORMED LENS WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14344091 ↗MalfunctionApr 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN ASSISTANT REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE STRING WAS FOUND ON THE LENS. ADDITIONAL INFORMATION REQUESTED AND RECEIVED STATED THAT THE LENS WAS REMAINED IMPLANTED IN THE EYE.
Patient problems: Insufficient Information
MAUDE report 14235560 ↗InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEVERE BLURRY VISION, RESIDUAL HYPEROPIA AND REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 8 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 13512609 ↗MalfunctionFeb 2, 2022Scratched Material; Scratched Material
A SURGEON REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH ON THE IOL WAS NOTED. AS THE SCRATCH WAS AWAY FROM THE CENTER OF THE LENS SO SURGEON FELT IT WOULD NOT BE AN ISSUE. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AS THE REPORTER IS UNWILLING TO FOLLOW-UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13433700 ↗MalfunctionJan 11, 2022Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED VIA IOL REPLY CARD, STATING THAT THE LENS WAS DAMAGED WHILE BEING USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13227151 ↗MalfunctionOct 1, 2021Failure to Eject; Failure to Eject
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AN IOL BECAME STUCK IN THE CARTRIDGE. THERE WAS PATIENT CONTACT WITH THE DEVICE AND THE PROCEDURE WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12561736 ↗MalfunctionApr 12, 2021Device Damaged by Another Device; Device Damaged by Another Device
ADDITIONAL INFORMATION WAS PROVIDED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11649167 ↗MalfunctionMar 26, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS IOL) IMPLANT PROCEDURE, THERE WAS AN UNIDENTIFIED PLASTIC LIKE MATERIAL BEHIND THE LENS AFTER INSERTION. ADDITIONAL INFORMATION WAS PROVIDED THAT THE SURGEON NOTICED WHAT LOOKED LIKE CORTEX BEHIND THE LENS. THERE WERE NO ADDITIONAL ISSUES. AT SECOND DAY POST OP, THE PATIENT WAS DOING WELL. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FACILITY. THIS REPORT IS ASSOCIATED WITH 1OF 3.
Patient problems: Foreign Body In Patient
MAUDE report 11574641 ↗
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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