ACRYSOF® SA60WF (REF SA60WF.205)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652332675), received between Mar 12, 2021 and Jul 28, 2025 — classified as 4 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (8 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 Material8
- Defective Device6
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Crack1
- Failure to Advance1
- Material Opacification1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions8
- Blurred Vision1
- Eye Injury1
- Inflammation1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC BROKE UPON INJECTING THE IOL. HENCE THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. PROCEDURE WAS COMPLETED ON THE SAME DAY WITH REPLACEMENT LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22626967 ↗InjuryAug 6, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NURSE LOAD IOL INTO CARTRIDGE AND INJECTOR BUT DID NOT OBSERVED LENS BEFORE. THEN PASS TO SURGEON FOR IMPLANTATION. THIS WAS COMMON PRACTICE OF THE SITE AND NO PRIOR EVENT LIKE THIS. SURGEON NOTICED VACUOLE-LIKE AND SCRATCH MARK ON THE LENS AFTER LOADING INTO PATIENT¿S EYES AND HAD TO CUT THE LENS TO EXTRACT IT OUT IN THE SAME OPERATION. BUT HAD TO WIDEN THE CUT MARK TO REMOVE THE PIECES OF LENS OUT. A NEW IOL REPLACED IN THE SAME OPERATION BUT TOOK LONGER TIME TO FINISH AND AS A RESULT WOUND WAS WIDEN THAN USUAL HAD TO STITCH THE WOUND CLOSE. PATIENT HAD INFLAMMATION AND ANTIBIOTICS WAS GIVEN AFTER THE SURGERY AND DOES NOT REQUIRE ADDITIONAL HOSPITAL STAY. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3.
Patient problems: Eye Injury; Inflammation
MAUDE report 19919052 ↗InjuryDec 27, 2023Material Opacification; Material Opacification
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE IOL WAS EXPLANTED AND EXCHANGED WITH A PIGGYBACK LENS.
Patient problems: Visual Impairment
MAUDE report 18396754 ↗MalfunctionSep 26, 2023Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT LENS BODY HAD A CREVICE/SCRATCH NEAR THE MIDDLE. THE LENS WAS LEFT IMPLANTED IN PATIENT'S EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17819162 ↗MalfunctionJun 15, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17135662 ↗MalfunctionApr 28, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DAMAGED INTRAOCULAR LENS (IOL) AND WASTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16833307 ↗MalfunctionJan 11, 2023Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A STRING OR ABRASION ON THE OPTICS OF THE LENS AND WHICH COULD NOT REMOVE. THE LENS NOT REMOVED DUE TO INCREASED RISK OF COMPLICATION. THERE WAS NO NEGATIVE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16136125 ↗MalfunctionDec 8, 2022Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15940552 ↗MalfunctionAug 25, 2022Scratched Material; Scratched Material
AN INVENTORY COORDINATOR REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON FOUND THERE WAS A SCRATCH ON THE LENS HENCE THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15293200 ↗MalfunctionAug 16, 2022Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION NOTED LENS HAD MULTIPLE FOLDS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15236078 ↗MalfunctionJun 28, 2022Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED A LENS WAS DEFECTIVE AND NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14840873 ↗MalfunctionMay 26, 2022Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14510591 ↗InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCE. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS PHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 14410434 ↗MalfunctionApr 25, 2022Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED VIA REPLY CARD, THE LENS WAS DEFECTIVE NOT IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14192300 ↗InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TOO MUCH FAR-SIGHTED VISION. THE CLINICAL REASON WAS MECHANICAL COMPLICATION OF IOL. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 13899684 ↗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 13433871 ↗MalfunctionFeb 2, 2022Failure to Advance; Defective Device; Failure to Advance; Defective Device
A NON-HEALTHCARE PROFESSIONAL (PURCHASING) REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THAT THE LENS DAMAGED IN CARTRIDGE AND DID NOT ADVANCE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13423964 ↗MalfunctionSep 16, 2021Crack; Crack
A NURSE REPORTED THAT THE LENS WAS CRACKED DURING INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12481598 ↗MalfunctionApr 19, 2021Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD, THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS INSERTED AND REMOVED. ADDITIONAL INFORMATION WAS PROVIDED BY A NURSE/COA/DIRECTOR OF NURSING, THAT THE IOL WAS REMOVED DUE TO A SCRATCH ON THE OPTIC. THE PROCEDURE WAS COMPLETED THE SAME DAY. THE CAUSE OF THE EVENT IS UNKNOWN. THERE WAS NO PATIENT HARM AND THE PATIENT'S PROGNOSIS IS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11685397 ↗MalfunctionMar 12, 2021Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL WAS SCRATCHED. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 11478077 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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