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ACRYSOF® SN6AT8 (REF SN6AT8U210)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, 5.25 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 00380652278058), received between Jun 15, 2022 and Nov 5, 2022 — classified as 2 injuries.

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 Problem2

Patient problems

  • Blurred Vision2
  • Dizziness2
  • Corneal Edema1
  • Hyphema1
  • Inflammation1
  • Intraocular Pressure Increased1
  • Itching Sensation1
  • Visual Impairment1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO SEE, DIZZY. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Blurred Vision; Dizziness

    MAUDE report 15740862 ↗
  • InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATENT WAS UNABLE TO SEE AND WAS FEELING DIZZY. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT, 1 DAY POST OP PATIENT HAD OCULAR ITCHING. VISION WAS VERY BLURRY AND FOGGY. DUE TO INCREASED INFLAMMATION DIFLUPREDNATE QDAY DROP STARTED UNTIL NEXT APPOINTMENT. 1 WEEK POST-OP, THE PATIENT WAS HAVING MILD CORNEAL BULLOUS CHANGE SUPERIOR WHICH MAY BE CAUSING SOME VISUAL BLURRING - WILL BE DISCONTINUING DIFLUPREDNATE AS IT MAY BE INCREASING IOP AND CORNEAL EDEMA. MILD CORNEAL BULLOUS CHANGE SUPERIOR ARE IMPROVED SINCE STOPPING DIFLUPREDNATE. IOP IS IMPROVED BUT BORDERLINE OD S/P HYDRUS -INFERIOR MICROPHYPHEMA CONTINUED - NOT MUCH CHANGE COMPARED TO PRIOR VISIT. DEVELOPED HYPHEMA. CONTINUE PREDNISOLONE QID AND TAPER WEEKLY. THE LENS WAS EXCHANGED AND PATIENT IS DOING WELL POST-OPERATIVELY.

    Patient problems: Blurred Vision; Corneal Edema; Dizziness; Hyphema; Inflammation; Intraocular Pressure Increased; Itching Sensation; Visual Impairment

    MAUDE report 14699056 ↗

Other intraocular lens devices

All intraocular lens devices →

Sources and updates

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