AcrySof Toric Aspheric UV Absorbing IOL SA6AT3 (REF SA6AT3.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652335799), received between Apr 16, 2021 and Oct 20, 2023 — classified as 5 injuries, 1 malfunction.

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2023Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THERE WAS A SCRATCH OR MARK ON LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS PATIENT NOT SATISFIED WITH SCRATCH ON LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PROGNOSIS OF THE PATIENT WAS GOOD AND THE SYMPTOMS OF THE PATIENT IS RESOLVED. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17973176 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OPHTHALMOLOGIST REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISON, WORSE IN BRIGHT LIGHT, NEGATIVE DYSPHOTOPSIA. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. NO PATIENT HARM. PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15869480 ↗
• MalfunctionMar 14, 2022Difficult to Advance; Difficult to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS HAD PRESSURE OF REJECTION WHEN THE TECH FOLDED THE LENS AND PUSHED THROUGH THE CARTRIDGE. THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13759133 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIRECTOR OF NURSING REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRY VISION AND CLINICAL REASON FOR EXPLANT WAS REFRACTIVE SURPRISE/SUBOPTIMAL OUTCOME IN POST LASIK CATARACT SURGERY. THE LENS WAS EXCHANGED FOR ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13221872 ↗
• InjurySep 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A MATERIALS MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED BLURRED AND DECREASED VISION. THE CLINICAL REASON WAS DECENTERED PCIOL (POSTERIOR CHAMBER INTRAOCULAR LENSES). THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT LENS WAS REPLACED WITH DIFFERENT POWER AND SAME MODEL LENS.

  Patient problems: Blurred Vision

  MAUDE report 12487465 ↗
• InjuryApr 16, 2021Mechanical Problem; Mechanical Problem

  UPON FURTHER REVIEW IT WAS IDENTIFIED THAT IN THE SURGEON'S OPINION, THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE IOL WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment

  MAUDE report 11677887 ↗