ACRYSOF® SA60AT (REF SA60AT.220)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) SINGLE-PIECE ACRYLIC FOLDABLE IOL,UV-ABSORBING POSTERIOR CHAMBER LENS (IOL/PC),13.0mm LENGTH, 6.0mm BICONVEX OPTIC, PLANARHAPTICS. · Class 3 · Implant
Quick summary
This Alcon AcrySof SA60AT is a foldable plastic lens implanted in the eye during cataract surgery. The 36 reports mostly describe scratches or cracks in the lens material, haptics (the little arms) breaking during implantation, and the lens failing to eject from its inserter; a few mention blurred vision, eye inflammation or clouding of the lens years later. There are no deaths and 5 injuries. No recalls name this device.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00380652555845), received between Apr 16, 2021 and Jul 13, 2026 — classified as 5 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (9 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 Material9
- Break5
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available2
- Defective Device2
- Device Contamination with Chemical or Other Material2
- Device Dislodged or Dislocated2
- Failure to Advance2
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information13
- Blurred Vision2
- Inflammation1
- Posterior Capsule Opacification1
- Unspecified Tissue Injury1
- Visual Disturbances1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2026Material Twisted/Bent
A HEALTH PROFESSIONAL REPORTED THAT BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY IT WAS NOTICED THAT THE LENS HAD A DEFECTIVE HAPTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25798697 ↗InjuryApr 9, 2026Device Dislodged or Dislocated
AN ADMINISTRATIVE ASSISTANT REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE, THE PATIENT EXPERIENCED BLURRED VISION THE NEXT DAY. THE LENS WAS REMOVED AND REPLACED WITH A COMPANY LENS OF DIFFERENT MODEL AND HALF DIOPTER MORE POWER SULCUS LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS THAT THE LENS WAS UNSTABLE IN THE PATIENT'S EYE. THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Blurred Vision
MAUDE report 24831881 ↗MalfunctionDec 12, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, HAPTIC WAS BROKEN DURING IMPLANTATION. THERE WAS NO PATIENT CONTACT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796861 ↗InjuryNov 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, VITREOUS INFLAMMATION OCCURRED WITHIN THE SECOND WEEK AFTER SURGERY. THE PATIENT WAS CURRENTLY UNDERGOING TREATMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED STATING LENS WAS NOT EXPLANTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 4 OF 4.
Patient problems: Inflammation
MAUDE report 23563734 ↗MalfunctionSep 18, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
BASED ON NEW INFORMATION RECEIVED ON 23-SEP-2025, IT WAS CLARIFIED THAT THE HAPTIC WAS INTACT AND NOT TORN OR BROKEN. THE ISSUE WAS LIMITED TO A CRACK IN THE IOL ITSELF. THE SURGEON NOTICED THE CRACK AFTER THE IOL WAS INSERTED AND POSITIONED. CONSEQUENTLY, THE IOL WAS REMOVED DURING SAME PROCEDURE. ACCORDING TO THE TECHNICIAN INVOLVED, THE LENS WAS STILL UPON LOADING. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23082055 ↗InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, FOUR YEARS AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, PARS PLANA VITRECTOMY (PPV) WAS PERFORMED ON THE RIGHT EYE DUE TO VITREORETINAL TRACTION. DURING THIS PROCEDURE, A BEGINNING POSTERIOR CAPSULE OPACIFICATION WHICH WAS SUBJECTIVELY UNNOTICED WAS REMOVED. THE PATIENT HAD A CLEAR VISION IN THE RIGHT EYE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE POSTERIOR CAPSULE OPACIFICATION (PCO) WAS TREATED ON (B)(6) 2019.
Patient problems: Posterior Capsule Opacification
MAUDE report 23001825 ↗MalfunctionAug 25, 2025Material Opacification; Material Opacification
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, 10 YEARS AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT WAS INCREASINGLY SEEING A VEIL OF GRAY IN ONE EYE. THE OPHTHALMOLOGIST SAID THAT IT WAS NOT A SECONDARY CATARACT, BUT THE LENS ITSELF THAT HAD BECOME CLOUDY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE OPHTHALMOLOGIST INFORMED THE PATIENT THAT THE ISSUE IN THE LEFT EYE (OS) WAS NOT A POSTERIOR CAPSULE OPACIFICATION BUT RATHER AN OPACIFICATION OF THE LENS. A REPLACEMENT OF THE LENS IS CURRENTLY NOT PLANNED AS THE PATIENT WAS STILL HAVING GOOD VISUAL ACUITY.
Patient problems: Visual Disturbances
MAUDE report 22885035 ↗MalfunctionAug 7, 2025Product Quality Problem; Product Quality Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT AND INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURES PERFORMED ON THE SAME DAY, TWO DEFECTIVE LENSES OF THE SAME MODEL AND DIOPTER WERE IDENTIFIED. OF THE TWO, ONE LENS WAS FOUND TO BE CONTAMINATED AND WAS SUBSEQUENTLY DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22740296 ↗MalfunctionAug 7, 2025Product Quality Problem; Product Quality Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT AND INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURES PERFORMED ON THE SAME DAY, TWO DEFECTIVE LENSES OF THE SAME MODEL AND DIOPTER WERE IDENTIFIED. OF THE TWO, ONE LENS WAS FOUND TO BE CONTAMINATED AND WAS SUBSEQUENTLY DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22740294 ↗MalfunctionJul 24, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTICS WERE STUCK ON THE OPTICS. SO, IT WAS DIFFICULT TO UNFOLD AND TOOK A LONG TIME AND A LOT OF MANIPULATION BEFORE THEY EVENTUALLY UNFOLDED. HENCE THE SURGEON HAD TO USE A FORCEPS IN THE END TO LIFT THE HAPTICS OFF AND THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588359 ↗MalfunctionJun 5, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE HAPTIC WAS BROKEN. THE SURGERY WAS COMPLETED WITH UNSPECIFIED REPLACEMENT LENS OF SAME DIOPTER. THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22150601 ↗MalfunctionFeb 12, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS JAMMED AND DID NOT ENGAGE AND THERE WAS SOME PROBLEM WITH HAPTIC. THERE WAS NO PATIENT CONTACT. THERE ARE SIX FILES ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21363615 ↗MalfunctionOct 25, 2024Failure to Advance; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY THEY HAVE NOTICED THAT THE LENS WAS STUCK IN LOADING CHAMBER. ADDITIONAL INFORMATION HAS BEEN RECEIVED IT STATES THAT PROCEDURE IS COMPLETED BY USING BACK UP LENS.
Patient problems: Insufficient Information
MAUDE report 20531819 ↗MalfunctionJul 16, 2024Break; Failure to Eject; Break; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS BROKEN AND TRAPPED IN THE CARTRIDGE. THE SURGERY WAS CARRIED OUT WITH ANOTHER LENS WITHOUT ANY PROBLEM AND THE PATIENT WAS WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19752598 ↗MalfunctionJul 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PHYSICIAN REPORTED ABOUT A LUXATED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19701250 ↗MalfunctionMay 13, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF WHILE IN SURGERY THE SURGEON NOTICED THAT THE LENS WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE SURGERY COMPLETED WITHOUT PROBLEM AND PATIENT RECOVERED WITH NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19296629 ↗MalfunctionMar 4, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS DENTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18825627 ↗MalfunctionDec 15, 2023Defective Component; Failure to Eject; Defective Component; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK WITH PLUNGER AND SURGEON TRIED TO PULL OUT AND CAUSE HAPTIC BROKEN. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE SURGERY WAS COMPLETED WITH BACKUP LENS WITHOUT COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18335197 ↗MalfunctionDec 8, 2023Scratched Material; Appropriate Device Problem Term/Code Not Available; Scratched Material; Appropriate Device Problem Term/Code Not Available
A FACILITY REPRESENTATIVE REPORTED ABOUT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED DURING THE INITIAL PROCEDURE DUE TO SCRATCH ON THE IOL FROM A LOADING ERROR. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18289952 ↗MalfunctionAug 21, 2023Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INTRAOCULAR LENS WAS FOUND TO BE DEFECTIVE. HENCE THE LENS WAS REMOVED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, DURING SURGERY, THE SURGEON NOTICE THE LENS WAS DEFECTIVE AND USED ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 17582842 ↗MalfunctionJun 1, 2023Break; Failure to Advance; Break; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN INJECTED THE INTRAOCULAR LENS INTO THE EYE, THE POSTERIOR HAPTIC WAS MISSING. IT WAS STUCK TO THE INJECTOR. THEN IT WAS REMOVED AND IMPLANTED ANOTHER ONE. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. SURGERY WAS COMPLETED AT THE SAME TIME. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17037456 ↗MalfunctionApr 25, 2023Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTICED SCRATCH AFTER INSERTION OF LENS. THE PROCEDURE IS COMPLETED BY REPLACING THE WITH NEW LENS. THERE WAS PATIENT CONTACT NOTED. ADDITIONAL INFORMATION HAS RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16806151 ↗MalfunctionMar 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A STREAKS/THREADS WERE NOTED ON THE IOL. THE LENS WAS REMAIN IMPLANTED AS THE SURGEON SAID THAT IT ACTS LIKE A MEMBRANE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE STREAKS/ THREADS COULD NOT BE POLISHED AWAY DURING THE SURGERY AS THEY STICK TO THE IOL. THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16576599 ↗MalfunctionFeb 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT DEFECTIVE LABEL WAS FOUND AND WAS NOT FULLY VISIBLE AND IOL WAS IMPLANTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16370126 ↗MalfunctionJan 4, 2023Scratched Material; Scratched Material
ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE SURGEON AND STATED THAT, SINCE PATIENT IS 90 YEARS OLD AND NOT REPORTING ON VISUAL DISTURBANCES, SURGEON DECIDED THERE IS NO NEED FOR EXPLANTATION OF IOL.
Patient problems: Insufficient Information
MAUDE report 16093124 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.