ACRYSOF® SN6AT6 (REF SN6AT6.190)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, 3.75 D CYLINDER. · Class 3 · Implant
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652274319), received between Jul 31, 2021 and Mar 4, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Eject” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Failure to Eject1
Patient problems
- Insufficient Information1
- Toxic Anterior Segment Syndrome (TASS)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE OBSERVED INJECTION ISSUE WITH LENS INTO THE EYE. THERE WAS PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18825101 ↗InjuryJul 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHARMACIST REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AFTER USE OF A VISCOELASTIC PRODUCT IN AN INTRAOCULAR LENS IMPLANTATION SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS FILE REPRESENTS PATIENT 2 OF 2 FROM THIS FACILITY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SURGEON ALSO SUSPECTED THE INTRAOCULAR LENS (IOL) ALSO AS A CAUSE OF EVENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT TASS WITH DIFFUSE CORNEAL EDEMA IN A CATARACT SURGERY IN THE LEFT EYE WAS OBSERVED.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 12257191 ↗
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 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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