ACRYSOF® SN6AT4 (REF SN6AT4.110)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, 2.25 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652250245), received between May 10, 2021 and Dec 31, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Malposition of Device” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Malposition of Device1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED STARBURST/STREAKS/GLARE WHICH IS EVIDENT WITH ANY LIGHT SOURCE (RED, BLUE, GREEN, WHITE) AND DRIVING AT NIGHT IS DEBILITATING DUE TO THE GLARE AND STREAKS FROM HEADLIGHTS. THE YAG (YTTRIUM ALUMINUM GARNET) PROCEDURE ALSO PERFORMED ON (B)(6) 2021. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances
MAUDE report 13125368 ↗InjuryMay 10, 2021Malposition of Device; Malposition of Device
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS SHIFTED IN THE EYE. THE IOL WAS EXCHANGED IN A SECOND PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON THAT THE DISLOCATION OF THE IOL INTO THE ANTERIOR VITREOUS WAS CAUSED BY A POSTERIOR CAPSULAR TEAR.
Patient problems: Capsular Bag Tear
MAUDE report 11800973 ↗
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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