ACRYSOF® SA60AT (REF SA60AT.200)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
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380652555807), received between Jul 15, 2021 and Dec 15, 2025 — classified as 2 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Defective Device” (5 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
- Defective Device5
- Scratched Material5
- Material Twisted/Bent3
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Dent in Material1
- Device Contamination with Chemical or Other Material1
- Device Damaged by Another Device1
Patient problems
- Insufficient Information11
- No Clinical Signs, Symptoms or Conditions6
- Endophthalmitis1
- Intraocular Infection1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN DURING IMPLANTATION. THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER COMPANY LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809863 ↗MalfunctionNov 7, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED WITH A DESCRIPTION OF STRAIGHT HAPTIC. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23498078 ↗MalfunctionFeb 25, 2025Material Twisted/Bent; Material Twisted/Bent
A PHARMACIST REPORTED THAT, BEFORE THE INTRAOCULAR LENS IMPLANTATION SURGERY, WHEN THE LENS WAS EXAMINED UNDER THE MICROSCOPE, IT SHOWS THAT THE LENS WAS IN POOR CONDITION, IT LOOKS BENT AND WAS NOT IN ITS NORMAL PRESENTATION. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 21458786 ↗MalfunctionJan 10, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE INTRAOCULAR LENS OPTIC WAS SCRATCHED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21124649 ↗MalfunctionOct 4, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF SCRATCHES ON THE INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS RECEIVED, THE SURGICAL TECH LOADED THE COMPANY LENS 20.0 D INTO THE CARTRIDGE WITH COMPANY PUSHER. THE LENS WENT IN AND THERE WERE SCRATCHES ON TOP OF LENS, HAD TO CUT LENS AND TAKE THEM OUT OF THE EYE AND CHANGE INTO NEW LENS OF SAME DIOPTER AND MODEL.
Patient problems: Insufficient Information
MAUDE report 20371610 ↗MalfunctionAug 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS DISLOCATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19948217 ↗MalfunctionJul 1, 2024Dent in Material; Dent in Material
A PHYSICIAN REPORTED THAT DURING THE PHACOEMULSIFICATION SURGERY UPON IMPLANTATION OF INTRAOCULAR LENS (IOL) IMPLANT NOTICED A NOTCH ON THE LENS. THE LENS WAS CUT OUT AND REPLACED WITH NEW LENS DURING INITIAL PROCEDURE.ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19645537 ↗MalfunctionApr 5, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF SCRATCHES ON INTRAOCULAR LENSES (IOLS). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19049219 ↗MalfunctionMar 1, 2024Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE LENS WAS FOUND DEFECTIVE. THE LENS WAS INSERTED AND REMOVED IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18815317 ↗MalfunctionJul 12, 2023Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OL PRESENTED A DEFECT IN THE OPTICAL CENTER THAT WOULD COMPROMISE THE VISUAL QUALITY. IOL WAS REMOVED FROM THE EYE AND A NEW IOL WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS NO PATIENT HARM REPORTED.
Patient problems: Insufficient Information
MAUDE report 17305007 ↗MalfunctionMay 31, 2023Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OL PRESENTED A DEFECT IN THE OPTICAL CENTER THAT WOULD COMPROMISE THE VISUAL QUALITY. IOL WAS REMOVED FROM THE EYE AND A NEW IOL WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17032694 ↗MalfunctionApr 25, 2023Defective Device; Defective Device
A NON HEALTH CARE PROFESSIONAL (TEAM LEADER) REPORTED THAT DURING THE INTRAOCULAR LENS (IOL), IMPLANT PROCEDURE LENS FOUND BE A DAMAGED. THERE ARE TWELVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 10 OF 12. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16807510 ↗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 16289987 ↗MalfunctionDec 28, 2022Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE OPTIC FOUND TO BE SCRATCHED AFTER IMPLANTATION IN THE EYE. THE SURGEON EXPLANTED THE LENS WITH NEW ONE. THE SURGERY WAS COMPLETED WITHOUT ANY PATIENT ADVERSE EVENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16060780 ↗MalfunctionNov 29, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A FOREIGN SUBSTANCE LIKE A THIN FILM AND REMOVED THROUGH IRRIGATION/ASPIRATION AFTER SEPARATING THE MATERIAL FROM THE LENS WITH A CHOPPER. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15876518 ↗InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT A PATIENT EXPERIENCED ENDOPHTHALMITIS IN THE OPERATED EYE THAT WAS NOTED DURING THE POST-OPERATIVE CHECK-UP. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Patient problems: Endophthalmitis
MAUDE report 13635995 ↗MalfunctionJan 17, 2022Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13264332 ↗MalfunctionJan 3, 2022Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS COMPLETELY HALVED. THE LENS WAS PROBABLY DAMAGED DURING APPLICATION BY A BAD CARTRIDGE MOLDING. THE LENS HAD TO BE EXPLANTED AND THEN A NEW IOL APPLIED. SURGERY GOT DELAYED BUT THE PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13141209 ↗MalfunctionJul 15, 2021Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WAS BENT & SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12173039 ↗
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.
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