ACRYSOF® SA60WF (REF SA60WF.245)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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652332750), received between Mar 4, 2022 and Mar 7, 2025 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other 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
- Device Contamination with Chemical or Other Material3
- Adverse Event Without Identified Device or Use Problem1
- Defective Device1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Blurred Vision1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL HAD A SCRATCH. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21545942 ↗MalfunctionJul 31, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAD LESIONS AND APPEARED TO BE FAULTY. THE SURGEON REALIZED THE PROBLEM AFTER IMPLANTATION, SO THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE WITHOUT APPARENT PROBLEMS FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19869832 ↗InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED DECREASED QUALITY OF VISION, BLURRY VISION EVEN WITH GLASSES. THE IOL WAS REPLACED WITH OTHER COMPANY LENS APPROXIMATELY ONE YEAR AFTER INITIAL PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision
MAUDE report 18902806 ↗MalfunctionMay 30, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) AFTER INSERTING LENS INTO THE PATIENT'S EYE NOTICED FROM THE MICROSCOPE THAT THE LENS HAD A BLUE ELONGATED THREAD IN OPTIC BODY AND TRIED TO REMOVE IT WITH THE IRRIGATING PROBE AND BSS (BALANCED SALT SOLUTION) WATER AND FINALLY REMOVED IT. THE INTRAOCULAR LENS WAS NOT REMOVED FROM THE PATIENT'S EYE. THERE WAS NO PATIENT HARM. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR FILE 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14539640 ↗MalfunctionMay 29, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) AFTER INSERTING LENS INTO THE PATIENT'S EYE NOTICED FROM THE MICROSCOPE THAT THE LENS HAD A BLUE ELONGATED THREAD IN OPTIC BODY AND TRIED TO REMOVE IT WITH THE IRRIGATING PROBE AND BSS (BALANCED SALT SOLUTION) WATER AND FINALLY REMOVED IT. THE INTRAOCULAR LENS WAS NOT REMOVED FROM THE PATIENT'S EYE. THERE WAS NO PATIENT HARM. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14538805 ↗MalfunctionMar 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AN INVENTORY MANAGEMENT SPECIALIST REPORTED THAT DURING INTRAOCULAR LENS IMPLANT PROCEDURE, DEBRIS ON LENS WAS OBSERVED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WERE CRYSTALS ON THE OPTIC, SO THE LENS WAS EXPLANTED DURING THE INITIAL PROCEDURE AND IMPLANTED WITH NEW LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13667658 ↗
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