AcrySof Toric Aspheric UV Absorbing IOL SA6AT4 (REF SA6AT4.180)Recalls & reported problems
Alcon Laboratories, Inc. · The AcrySof Aspheric UV Absorbing Toric Posterior Chamber Intraocular Lens (IOL) is a UV Absorbing foldable intraocular lens (IOL) · Class 3 · Implant
All models of AcrySof Toric Aspheric UV Absorbing IOL (56)
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 00380652336253), received between Jul 14, 2021 and Sep 2, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED AFTER SURGERY THAT, PATIENT EXPERIENCED BLURRY VISION WITH DRIVING AND READING, AND WAS UNABLE TO SEE CASH REGISTER AT WORK. THE CLINICAL REASON FOR EXPLANT WAS IOL ROTATION AND WAS REPLACED WITH ATIOL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT LENS HAD ROTATED 005 DEGREES SINCE ORIGINAL CATARACT SURGERY. THERE WAS NO PATIENT HARM AND PATIENT WAS NO HOSPITALIZED.
Patient problems: Blurred Vision
MAUDE report 15345202 ↗InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE 18.0 LENS WAS EXCHANGED FOR A21.0 LENS DUE TO UNHAPPY VISION. THIS DOES NOT MEET CRITERIA FOR REPORTING BASED ON APPLICABLE MEDICAL DEVICE REGULATIONS. A LENS EXCHANGE FROM ONE POWER TO A DIFFERENT POWER IS AN ATTEMPT TO ADJUST OR FINE TUNE THE REFRACTIVE OUTCOME TRYING TO ACHIEVE A DESIRED TARGET WHEN THE INITIAL LENS CALCULATIONS DID NOT ACHIEVE THE INTENDED OUTCOME. THERE IS NO REPORTED DEFECT OR FAULT WITH THE LENS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12166938 ↗
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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