ACRYSOF® SN6AT3 (REF SN6AT3.070)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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652249638), received between May 10, 2022 and May 10, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Material Opacification1
Patient problems
- Burning Sensation1
- Dry Eye(s)1
- Headache1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2022Material Opacification; Device Contamination with Chemical or Other Material; Material Opacification; Device Contamination with Chemical or Other Material
A CONSUMER REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION SHE STARTED NOTICING A FEELING OF SOMETHING IN EYE OR IT'S SCRATCHED, ALMOST LIKE A BURNING, A REALLY WEIRD FEELING. THE PATIENT REPORTED THAT THE FEELING GETS REALLY BAD, AND GIVES HORRIBLE HEADACHES. THE PATIENT REPORTED THAT SHE ALSO KEEPS GETTING CLOUDINESS OVER THAT EYE, WHICH MAKES IT DIFFICULT TO SEE AT NIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE QUALITY ISSUE WAS NOT DUE TO THE LENS BUT IS MOST LIKELY DUE TO DRY EYE. THERE WAS NO HARM TO THE PATIENT AND THE PROGNOSIS WAS GOOD. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.
Patient problems: Burning Sensation; Dry Eye(s); Headache
MAUDE report 14346736 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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- 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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