ACRYSOF® SN6AT3 (REF SN6AT3.230)Recalls & reported problems

Alcon Laboratories, Inc. · AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 1.50 D CYLINDER. · Class 3 · Implant

All models of ACRYSOF (353)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 8
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652249959), received between Apr 12, 2021 and Mar 18, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 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

Adverse Event Without Identified Device or Use Problem3
Scratched Material3
Device Damaged by Another Device2
Crack1
Defective Device1

Patient problems

No Clinical Signs, Symptoms or Conditions3
Insufficient Information2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Blurred Vision1
Capsular Bag Tear1
Eye Injury1
Visual Disturbances1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THERE WAS A POSTERIOR CAPSULAR RUPTURE WHEN INJECTING THE INTRAOCULAR LENS, THE LENS WAS REMOVED AND REPLACED WITH THE COMPANY LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT UNDERWENT ANTERIOR VITRECTOMY. THERE WAS NO PATIENT HARM AND THE SYMPTOMS WERE RESOLVED.
Patient problems: Capsular Bag Tear
MAUDE report 21630048 ↗
MalfunctionOct 17, 2023Device Damaged by Another Device; Scratched Material; Device Damaged by Another Device; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE NOTICED THAT THE LENS WAS SCRATCHED ON OUTSIDE EDGE AFTER INSERTION. THE LENS WAS STILL IMPLANTED IN THE EYE. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17949091 ↗
MalfunctionAug 16, 2023Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS NOTED TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17553848 ↗
MalfunctionSep 29, 2022Device Damaged by Another Device; Device Damaged by Another Device
A OPHTHALMIC SURGEON REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WAS FIRMLY ATTACHED TO THE IOL. WHEN ATTEMPTING TO RETRACT THE PLUNGER, THE IOL RUPTURED. SURGERY WAS COMPLETED WITH A REPLACEMENT LENS. THERE WAS PATIENT CONTACT INVOLVED, HOWEVER NO PATIENT HARM AND THE PATIENT WAS NOT HOSPITALIZED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15507501 ↗
MalfunctionSep 5, 2022Crack; Scratched Material; Crack; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAS CRACKED. THE IOL WAS IMPLANTED AND REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15355777 ↗
MalfunctionDec 13, 2021Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS HAD A SCRATCH AFTER IMPLANTATION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12987632 ↗
InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT WAS SEEING YELLOW SPOTS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE 12 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 12479742 ↗
InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HER SURGEON HAS INFORMED HER SHE HAS SOME RESIDUAL SWELLING IN HER RETINA FROM SURGERY. HE'S CONTINUED HER ON 2 DROPS AND IS FOLLOWING UP WITH HER NEXT WEEK. IN A FOLLOW UP WITH THE PATIENT, HER SWELLING IS GOING DOWN AND HER VISION HAS IMPROVED. SHE IS STILL ON HER EYE DROPS AND HAS HER NEXT FOLLOW UP IN MID-APRIL. SHE WILL UPDATE US IF ANYTHING CHANGES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Eye Injury
MAUDE report 11649366 ↗

Device details

UDI-DI	`00380652249959`
Brand	ACRYSOF®
Model	SN6AT3
Catalog no.	SN6AT3.230
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.

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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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