ACRYSOF® SA60WF (REF SA60WF.225)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
Quick summary
This Alcon AcrySof SA60WF is a foldable artificial lens implanted in the eye during cataract surgery. Most of the 30 reports describe the lens being scratched, jammed or stuck as it was loaded or inserted, haptics (the small arms) breaking off or fusing to the optic, and a thin eye capsule tearing during implantation. The reports mention 5 injuries and no deaths. There are no recalls naming this device, and reports have dropped from 6 in the previous 12 months to 2 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380652332712), received between Mar 9, 2021 and Aug 25, 2026 — classified as 5 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material7
- Defective Device5
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Defective Component2
- Device Contamination with Chemical or Other Material2
- Dent in Material1
- Device Damaged by Another Device1
Patient problems
- Insufficient Information13
- No Clinical Signs, Symptoms or Conditions13
- Blurred Vision2
- Capsular Bag Tear2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Failure to Unfold or Unwrap
A non-health care professional reported with a description that, the implant had one of it's haptics which was found to be fused to the optic, thereby preventing its normal use. According to the surgeon, this type of defect has never been encountered during many years of experience using the company intraocular lenses. Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50431131 ↗MalfunctionNov 12, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS JAMMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23532835 ↗MalfunctionOct 22, 2025Material Deformation; Material Deformation
ADDITIONAL INFORMATION REQUESTED AND RECEIVED STATING THAT LENS WAS FOUND TO BE DAMAGED INSIDE THE PATIENT¿S EYE. THE LENS THAT WAS IMPLANTED IN THE PATIENT¿S EYE WAS PLACED IN THE LEFT EYE.
Patient problems: Insufficient Information
MAUDE report 23358172 ↗MalfunctionJul 11, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED A LACK OF HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22480643 ↗MalfunctionJul 11, 2025Dent in Material; Dent in Material
A HEALTHCARE PROFESSIONAL REPORTED THAT, WITH A DESCRIPTION THAT, A LINE PASSES THROUGH THE CENTER OF THE LENS.
Patient problems: Insufficient Information
MAUDE report 22478107 ↗InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE POSTERIOR CAPSULE RUPTURED WHEN IMPLANTING THE LENS. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME SURGERY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, IT WAS A POLAR CATARACT WITH A THIN LAYER OF CAPSULE, UPON INJECTING THE LENS, THE THIN CAPSULE TORN.
Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions
MAUDE report 22063762 ↗MalfunctionMay 12, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE HAPTIC BROKE. THE LENS WAS REMOVED. ADDITIONAL INFORMATION REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22001490 ↗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 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20649820 ↗InjurySep 25, 2024Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS UNFOLDED IN FAST ACTION. THE LEADING HAPTIC SCRATCHED THE POSTERIOR CAPSULE BAG, AND THE IOL WAS DROP INTO POSTERIOR SEGMENT OF THE EYE. ON THE SAME DAY, A VITREORETINAL SURGERY WAS PERFORMED TO EXPLANT THE LENS AND LENS WAS EXCHANGED WITH ANTERIOR CHAMBER IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 20304986 ↗MalfunctionApr 1, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL WAS BLOCKED IN CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19010278 ↗MalfunctionMay 29, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION BLUE DEBRIS NOTED ON LENS WHILE IN CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17016765 ↗MalfunctionMay 4, 2023Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL FOUND TO BE DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16871017 ↗MalfunctionFeb 13, 2023Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SCRATCH WAS NOTED ON THE LENS. THERE WAS A PATIENT CONTACT, AND THE SURGERY WAS COMPLETED WITH THE BACKUP LENS. THERE WAS NO SERIOUS INJURY TO THE PATIENT AND THERE WAS NO SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16367132 ↗InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CLINICAL MANAGER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRY/HAZY VISION. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE WITHIN 3 MONTHS AND REPLACED WITH MONOFOCAL IOL. THE CLINICAL REASON FOR EXPLANT WAS REPORTED AS MECHANICAL DEFECT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 16205688 ↗InjuryOct 17, 2022Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISUAL ACUITY TO 20/25 BY DAY 11, AND THE CLINICAL REASON WAS INFERIOR DELOCATION AND DEFECT WAS NOTED IN THE INFERIOR HAPTIC. THE IOL WAS EXPLANTED AND EXCHANGED IN A SECONDARY PROCEDURE FOR A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 15620558 ↗InjuryOct 13, 2022Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DEFECTIVE HAPTIC. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15596690 ↗MalfunctionJun 30, 2022Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A VERY CLEAR MARK OR SCRATCH WAS OBSERVED IN THE MIDDLE OF THE LENS AFTER THE IOL WAS DELIVERED IN THE BAG. THE LENS HAS BEEN CUT FOR REMOVAL FROM THE PATIENT¿S EYE. THE REPLACEMENT LENS WAS USED AND THE SURGERY WAS COMPLETED. THERE WAS PATIENT CONTACT WITH THE PRODUCT BUT NO PATIENT HARM WAS REPORTED. THE PATIENT'S SYMPTOMS WERE RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED STATING CUSTOMER DON¿T KNOW WHY OR WERE THE MARK/ SCRATCH CAME FROM. THEY MORE LIKELY THINK THAT IT WAS FROM THE FORCEPS, OR THE HANDPIECE PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14877412 ↗MalfunctionApr 28, 2022Defective Device; Defective Device
A FACILITY REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A LENS WAS DEFECTIVE NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14233876 ↗MalfunctionMar 30, 2022Scratched Material; Scratched Material
A FACILITY REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT IMPLANTED DUE TO A MARK ON IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13952390 ↗MalfunctionFeb 9, 2022Difficult to Advance; Difficult to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON HAD DIFFICULTY INJECTING LENS INTO THE PATIENTS RIGHT EYE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13495803 ↗MalfunctionFeb 2, 2022Failure to Advance; Failure to Advance
A NON HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS STUCK IN THE INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT AND THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. NO MEDICAL OR SURGICAL INTERVENTION NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13421388 ↗MalfunctionDec 23, 2021Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED AND THERE WAS A CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13080183 ↗MalfunctionNov 12, 2021Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED AN INTRAOCULAR LENS (IOL) WITH A DESCRIPTION OF THERE WAS ISSUE WITH THE LENS IN THE INSERTER AND THE PATIENT CONTACT WAS NOTED BUT PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT, IOL WAS DAMAGED IN THE INJECTOR AND THE IOL WAS TOUCHED THE EDGE OF HE EYE. AS PER THE SURGEONS OPINION, LOADING ERROR OR INJECTOR ISSUE WAS CONTRIBUTORY FOR THE IOL DAMAGED. THE LENS WAS REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12805240 ↗MalfunctionAug 30, 2021Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12385522 ↗MalfunctionJul 23, 2021Scratched Material; Scratched Material
ADDITIONAL INFORMATION RECEIVED VIA REPLY CARD AND PATIENT DETAILS HAS BEEN UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12216967 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.