ACRYSOF® SA60AT (REF SA60AT.175)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: 10
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652555753), received between May 6, 2021 and Sep 18, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Defective Device4
Device Contamination with Chemical or Other Material3
Break1
Material Deformation1
Scratched Material1

Patient problems

Insufficient Information7
No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 18, 2025Material Deformation; Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED DURING SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23086230 ↗
MalfunctionFeb 26, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BROKE OFF. SURGEON REMOVED LENS HAPTIC AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS EXPLANTED AND REPLACED WITH SAME MODEL SAME DIOPTER COMPANY LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: Insufficient Information
MAUDE report 21468288 ↗
MalfunctionDec 27, 2024Defective Device; Defective Device
A CONSUMER REPORTED VIA COMPANY REPRESENTATIVE WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL) FOUND FAULTY IN THEATRE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21026935 ↗
MalfunctionJun 10, 2024Defective Device; Defective Device
IN THE END, IT WAS JUST A CONTAMINATED LENS. AND PROCEDURE COMPLETED WITH A SECOND LENS. AND COMPLETED SURGERY WITH NO PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 19497466 ↗
MalfunctionMay 2, 2023Device 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 STRIPES/THREADS ON INTRAOCULAR LENS. SOME OF THE STRIPES/THREADS COULD BE POLISHED AWAY, SOME WERE NOT POSSIBLE TO REMOVE. THE LENS WAS IMPLANTED BUT NOT EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16853379 ↗
MalfunctionMar 15, 2023Defective Device; Defective Device
AN OTHER HEALTH CARE PROFESSIONAL REPORTED ABOUT FAULTY LENSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16545026 ↗
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 FOUR OF SEVEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16364222 ↗
MalfunctionFeb 8, 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 IOL. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS FOR TWO OF FOUR.
Patient problems: Insufficient Information
MAUDE report 16325158 ↗
MalfunctionOct 26, 2021Defective Device; Defective Device
A HEALTH PROFESSIONAL REPORTED THAT THE LENS FOUND TO BE DEFECTIVE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12697667 ↗
MalfunctionMay 6, 2021Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE IOL WAS IMPLANTED INTO THE PATIENT'S EYE, THE DOCTOR NOTICED A MARKING ON THE LENS. THE SURGEON WAS UNSURE IF IT WAS A SCRATCH MARK OR A FORCEPS MARK. THE IOL WAS REMOVED AND REPLACED WITH A NEW LENS TO COMPLETE THE PROCEDURE. THE PATIENT IS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11785729 ↗

Device details

UDI-DI	`00380652555753`
Brand	ACRYSOF®
Model	SA60AT
Catalog no.	SA60AT.175
Company	Alcon Laboratories, Inc.
Product code	HQL · intraocular lens
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 8, 2021

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Other intraocular lens devices

TECNIS IOL PCB00
Johnson & Johnson Surgical Vision, Inc. · intraocular lens
146 reports
TECNIS IOL PCB00
Johnson & Johnson Surgical Vision, Inc. · intraocular lens
145 reports
TECNIS IOL PCB00
Johnson & Johnson Surgical Vision, Inc. · intraocular lens
144 reports
TECNIS IOL PCB00
Johnson & Johnson Surgical Vision, Inc. · intraocular lens
139 reports
TECNIS SIMPLICITY DIB00
Johnson & Johnson Surgical Vision, Inc. · intraocular lens
1 recall81 reports
TECNIS IOL PCB00
Johnson & Johnson Surgical Vision, Inc. · intraocular lens
129 reports
TECNIS IOL PCB00
Johnson & Johnson Surgical Vision, Inc. · intraocular lens
127 reports
TECNIS IOL PCB00
Johnson & Johnson Surgical Vision, Inc. · intraocular lens
126 reports

All intraocular lens devices →

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