ACRYSOF® SA60AT (REF SA60AT.210)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
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof SA60AT is a foldable plastic intraocular lens implanted in the eye during cataract surgery. The 38 reports mostly describe the lens being scratched, cracked, torn, or snapped during handling and implantation, sometimes sticking in the injector cartridge so it would not come out, with the lens breaking into small pieces as it was removed. Four reports mention patient injury, including blurred vision and eye injury. No deaths were reported, and 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
- 40
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00380652555821), received between Feb 24, 2022 and Sep 25, 2026 — classified as 4 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (10 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
- Scratched Material10
- Break6
- Material Split, Cut or Torn4
- Crack3
- Material Opacification3
- Material Twisted/Bent3
- Adverse Event Without Identified Device or Use Problem2
- Defective Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information16
- Blurred Vision3
- Eye Injury2
- Capsular Bag Tear1
- Endophthalmitis1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Scratched Material
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, while loading the lens was found to be scratched/damaged. The procedure was completed on the same day. There was no contact between the patient eye and the device. The surgeon believed the lens was defective.Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894918 ↗MalfunctionSep 18, 2026Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826528 ↗MalfunctionMay 29, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, LENS WAS STUCK IN SHOOTER CARTRIDGE AND WAS NOT ABLE TO BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25330755 ↗MalfunctionApr 21, 2026Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LOADING OF LENS INTO THE COMPANY CARTRIDGE WITH A COMPANY INJECTOR THE PHYSICIAN STARTED THE IMPLANTATION OF THE IOL. HE NOTICED THAT THE TRAILING HAPTIC WAS CUT. THEN HE EXPLANTED THE DEFECTIVE IOL FROM THE PATIENT EYE AND REQUESTED NURSE TO OPEN ANOTHER SAME IOL FROM THEIR STOCK AND SUCCESSFULLY COMPLETED THE OPERATION ON THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24937873 ↗MalfunctionFeb 5, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE DOCTOR WAS ADVANCING THE LENS FOR IMPLANTATION, IT WAS NOTICED THAT THE LENS WAS STUCK IN CARTRIDGE AND WOULD NOT ADVANCE. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.
Patient problems: Insufficient Information
MAUDE report 24268358 ↗MalfunctionFeb 3, 2026Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY HAVE NOTICED MARK ON LENS. THE LENS CAME FRACTURED. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24247646 ↗MalfunctionDec 19, 2025Break; Break
A NURSE REPORTED WITH A DESCRIPTION OF BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23850875 ↗MalfunctionNov 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
THE NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD BROKEN AND WAS NOT IMPLANTED INTO THE PATIENT'S EYE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE ADDITIONAL MEDICAL DEVICE REPORTS LINKED TO THIS FILE. THIS PARTICULAR REPORT CORRESPONDS TO FILE 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645429 ↗MalfunctionNov 25, 2025Break; Break
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS BROKEN AND HENCE THE LENS WAS IMPLANTED AND EXPLANTED OUT OF PATIENT. ADDITIONAL INFORMATION RECEIVED AND STATED THAT IN SURGEON OPINION THE LENS APPEARED TO BE SPOILED AND THE HAPTIC BROKEN AND WHEN ATTEMPTED REMOVAL PRIOR TO REMOVING AS A WHOLE LITTLE PIECES BROKE OFF AND WAS REMOVED CONTRIBUTED TO THE EVENT. THE ISSUE WITH THE COMPLAINT WAS NOTICED UPON INSERTION INTO THE CAPSULAR BAG.
Patient problems: Insufficient Information
MAUDE report 23642235 ↗MalfunctionNov 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS TORN. THERE WAS PATIENT CONTACT AND NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23593309 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION OF THE COMPANY¿S 21.0 D INTRAOCULAR LENS, A CAPSULAR RUPTURE OCCURRED. IT WAS EXPLANTED THE SAME DAY AND REPLACED WITH A 3-PIECE COMPANY 21.0 D LENS. THERE WAS NO FURTHER IMPACT ON THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Capsular Bag Tear
MAUDE report 23579905 ↗MalfunctionOct 15, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY A CENTRAL SCRATCH ON THE IOL WAS OBSERVED THROUGH THE MICROSCOPE PRIOR TO IMPLANTATION. THE IOL WAS NOT IMPLANTED, AND THE SURGERY WAS COMPLETED USING A REPLACEMENT LENS. NO PATIENT CONTACT AND NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290842 ↗MalfunctionAug 19, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAPTIC WAS BROKEN/TORN/MISSING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE HAPTIC WAS DAMAGED DURING LOADING. THERE WAS PATIENT CONTACT BUT THE PATIENT DID NOT SUFFER ANY HEALTH DAMAGE. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED LENS. BECAUSE THE LENS CAME INTO CONTACT WITH THE PATIENT, IT WAS DISPOSED OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22839812 ↗MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONCE INJECTED, THE HAPTIC DID NOT HOLD THE LENS IN PLACE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22749693 ↗MalfunctionJul 4, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC ENTRAPMENT WAS EVIDENT IN THE INJECTOR. THE IMPLANTATION WAS COMPLETED BUT REMAINED WITHOUT HAPTIC SUPPORT. LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22403853 ↗MalfunctionMar 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING IMPLANTATION LENS WAS BROKEN IN THE INJECTOR. THE PRODUCT NOT APPLIED ON THE PATIENT. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21573284 ↗MalfunctionFeb 13, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION ATTEMPT, HAPTIC WAS TORN AND SURGERY COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT AND NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21372843 ↗InjuryNov 7, 2024Crack; Crack
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY HAVE NOTICED THAT THE LENS WAS CRACKED (POSSIBLY DUE TO CARTRIDGE). SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. PATIENT HAD AN ENLARGEMENT OF INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Injury
MAUDE report 20632144 ↗InjuryNov 7, 2024Crack; Crack
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY HAVE NOTICED THAT THE LENS WAS CRACKED (POSSIBLY DUE TO CARTRIDGE). SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. PATIENT HAD AN ENLARGEMENT OF INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Injury
MAUDE report 20631997 ↗MalfunctionOct 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TORN OF IOL WAS FOUND. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE HAPTIC DETACHMENT HAD OCCURRED WHILE THE LENS WAS PASSING THROUGH THE CARTRIDGE. SURGEON HAD TO CUT IT AND EXPLANT THE LENS FROM THE EYE AND IMPLANTED THE SAME IOL OF SAME DIOPTER IN THE EYE COMPLETED SURGERY ON SAME DAY. PATIENT'S CURRENT CONDITION WAS SATISFACTORY WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20554587 ↗MalfunctionSep 13, 2024Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT STUCK IN THE CARTRIDGE AND COULD NOT BE IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 20212250 ↗MalfunctionJul 25, 2024Dent in Material; Dent in Material
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION HOLE IN THE OPTICAL PART OF THE (IOL)INTRAOCULAR LENS. THE PATIENT HAD SCHEDULED A FOLLOW-UP TO CHECK WHETHER THIS WILL EFFECT ON THE VISION. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE PATIENT WAS FINE BUT SHE WAS THINKING TO REPLACE THE LENS. THE CENTRAL VISION WAS GOOD BUT HER PERIPHERAL VISION WAS WORSE DUE TO DAMAGE TO THE LENS.
Patient problems: Blurred Vision
MAUDE report 19828420 ↗MalfunctionJun 12, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT IOL WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19522503 ↗MalfunctionMay 9, 2024Material Opacification; Failure to Advance; Material Opacification; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STICKING TO THE TOP OF THE CARTRIDGE. THE DOCTOR APPLIED MORE VISCOELASTIC FOR LENS ADVANCEMENT. THE LENS WAS IMPLANTED BUT WHEN THE LENS WAS ROTATED, THE DOCTOR NOTICED A FOGGY CENTER PATCH WHICH DID NOT CLEAN. THEREFORE, THE LENS WAS REMOVED AND A COMPANY LENS OF SAME MODEL AND DIOPTER WAS PLACED DURING SAME PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19277802 ↗MalfunctionNov 20, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A PHYSICIAN REPORTED THAT DURING SURGERY, THE LENS WAS IMPLANTED. THE IOL DID NOT OPEN PROPERLY AND HAD TO BE EXPLANTED AGAIN. THERE WAS PATIENT CONTACT HOWEVER NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE IOL WAS REMOVED IN THE SAME PROCEDURE AND THE STANDBY LENS WAS IMPLANTED. THE SURGERY WAS COMPLETED WITH THE REPLACEMENT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18169672 ↗
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