ACRYSOF® SA60AT (REF SA60AT.225)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 29 reports mostly describe the lens being scratched, torn, cracked or cloudy when it was opened or inserted, and haptics (the small arms) sticking, twisting or falling off so surgeons had trouble unfolding them. Four reports involved injuries and no deaths. No recalls name this device, and reports fell from 8 to 3 over the past 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
- 31
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00380652555852), received between Sep 28, 2015 and Sep 22, 2026 — classified as 5 injuries, 26 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 Device3
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Failure to Unfold or Unwrap2
- Material Opacification2
- Material Split, Cut or Torn2
- Material Twisted/Bent2
Patient problems
- Insufficient Information14
- No Clinical Signs, Symptoms or Conditions13
- Blurred Vision2
- Dizziness1
- Intraocular Infection1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Product Quality Problem
A non-health care professional reported that during an intraocular lens (IOL) implant procedure, The implanted IOL was unusable upon/after implantation. The physician removed the lens and implanted a new replacement lens.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50855327 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
A facility representative reported that following an intraocular lens (IOL) implant procedure, the patient reason and clinical reason for explant being refractive surprise. The IOL was explanted and exchanged for an unknown advanced technology intraocular lens following the initial implant procedure.Additional information has been requested but is not available at the time of this report.
Patient problems: Visual Impairment
MAUDE report 50177260 ↗MalfunctionMay 12, 2026Scratched Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT UNDERWENT INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED A SCRATCH ON LENS AFTER IMPLANTING THE IOL INTO THE EYE. THE PHYSICIAN REMOVED THE FAULTY IOL AND REPLACED WITH AN ANOTHER IOL.
Patient problems: Insufficient Information
MAUDE report 25150533 ↗MalfunctionMay 12, 2026Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS WAS DAMAGED DURING LOADING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25147410 ↗MalfunctionDec 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING A INTRAOCULAR LENS IMPLANT PROCEDURE, OPTICS ARE TORN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23851618 ↗MalfunctionOct 24, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT DURING SURGERY, SURGEON NOTICED THAT THE IOL WAS CLOUDY RIGHT BEFORE IMPLANTATION, LEFT THE EYE APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23377057 ↗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 22588515 ↗MalfunctionApr 30, 2025Break; Break
PHYSICIAN DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED HAPTIC FELL OFF. THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH COMPANY ANOTHER LENS OF SAME MODEL AND DIOPTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934797 ↗MalfunctionMar 26, 2025Failure to Fold; Device Difficult to Setup or Prepare; Device Damaged by Another Device; Failure to Fold; Device Difficult to Setup or Prepare; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION, THE LENS WAS STIFF. THE PHYSICIAN TRIED TO INSERT THE LENS AND IT GOT SCRATCHED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696158 ↗MalfunctionMar 5, 2025Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC CRACKED AND OPTIC BODY DEFORMED. LENS WAS EXPLANTED IN INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21527214 ↗MalfunctionFeb 25, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS RIGID, DID NOT UNFOLD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21457821 ↗MalfunctionDec 13, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20923023 ↗MalfunctionDec 5, 2024Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED IN INITIAL PROCEDURE DUE TO MICROSCOPIC NIC IN THE CENTER OF THE IOL. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. THERE WAS NO PATIENT HARM. PATIENT SYMPTOMS WERE RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20856974 ↗MalfunctionOct 17, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF FAULTY LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20469004 ↗MalfunctionAug 22, 2024Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED, WITH A DESCRIPTION OF INTRAOCULAR LENS WAS INSERTED. SCRATCH NOTED. THE LENS WAS REMOVED, DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20042808 ↗MalfunctionAug 6, 2024Scratched Material; Scratched Material
ADDITIONAL INFORMATION RECEIVED STATING THAT PRODUCT WAS SCRATCHED WHEN OPENED.
Patient problems: Insufficient Information
MAUDE report 19919069 ↗MalfunctionJul 20, 2024Unintended Ejection; Unintended Ejection
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS DID NOT WORK PROPERLY GOING INTO CORNEA. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19787011 ↗MalfunctionFeb 5, 2024Scratched Material; Scratched Material
AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT AFTER PLACING THE INTRAOCULAR LENS (IOL) INTO PATIENT'S EYE, IT WAS NOTICED THAT THERE WERE VISIBLE SCRATCHES ON THE LENS. THE SURGEON TOOK THE DECISION TO LEAVE THE LENS IN PLACE AS IT WOULD NOT HAVE HAD IMPACT ON THE PATIENT'S CENTRAL VISION. THE SURGEON HAD EXPLAINED THE SCRATCHES TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS FINE, NOT AFFECTED BY GLARE AND THE VISION HAD IMPROVED. THERE WAS A FAINT TRIDENT LIKE MARK ON THE MARGIN OF THE OPTICAL LENS, WHICH LOOKED LIKE IT COULD BE DUE TO FOLDING THAT LEFT THE MARK IMPRINTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18638277 ↗MalfunctionDec 26, 2023Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT LENS WAS BENT UPON INSERTION TO CANNULA DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18392254 ↗MalfunctionNov 21, 2023Defective Device; Defective Device
THE LENS WAS REMOVED IN AN INITIAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18184111 ↗MalfunctionOct 16, 2023Unintended Ejection; Unintended Ejection
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH IOL IMPLANT, LENS CAME OUT OF CARTRIDGE BEFORE ENTERING EYE. SURGERY COMPLETED WITH A SECOND IOL. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17938864 ↗InjuryAug 17, 2023Material Opacification; Material Opacification
A PHYSICIAN REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PHYSICIAN FOUND THAT IOL TO HAVE OPACIFICATION. THERE WAS A NEED OF YTTRIUM ALUMINIUM GARNET (YAG) PROCEDURE AND REPLACED WITH ANOTHER COMPANY LENS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, FOLLOWING THE IOL IMPLANTATION IOL FOUND TO HAVE PROGRESSIVE OPACIFICATION. THE PATIENT HAD EXPERIENCED SEVERE LOW VISION. THE PATIENT HOSPITALIZED FOR EXPLANTATION/EXCHANGE OF IOL AND ANTERIOR VITRECTOMY.
Patient problems: Blurred Vision
MAUDE report 17564230 ↗InjuryJun 26, 2023Material Opacification; Material Opacification
A PHYSICIAN REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PHYSICIAN FOUND THAT IOL TO HAVE OPACIFICATION. THERE WAS A NEED OF YTTRIUM ALUMINIUM GARNET (YAG) PROCEDURE AND REPLACED WITH ANOTHER COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17198378 ↗MalfunctionFeb 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BLUE OR WHITE THREADS STUCK TO THE IOLS. ATTEMPTS WERE MADE TO POLISH AWAY THE THREAD. THERE WAS PATIENT CONTACT, BUT NO PATIENT HARM OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE SEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THREE OF SEVEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16364219 ↗InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENTS CAME IN POST-OPERATIVE FOLLOW-UP AND HE FOUND TO HAVE INFECTION AND REACTION. UNSPECIFIED MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Intraocular Infection
MAUDE report 16289988 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.