ACRYSOF® SN6AT4 (REF SN6AT4.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652250450), received between Mar 18, 2021 and Mar 18, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Failure to Deliver; Scratched Material; Failure to Deliver; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE INTRAOCULAR LENS WAS IN THE CHARGER BUT WOULD NOT ADVANCE, RESULTING IN SCRATCHES. THE PROCEDURE WAS COMPLETED WITH THE BACKUP LENS. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21629959 ↗
• InjuryNov 7, 2024Adverse 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 NAUSEA AND TRAPEZOID VISION ONLY UP CLOSE AND INTERMEDIATE. WHEN THE PATIENT COVER EACH EYE INDEPENDENTLY THE TRAPEZOID FLIPS. THE PATIENT VISION WAS GOOD BUT CLOSE VISION WAS DIFFICULT, CONSTANT NAUSEA AT NEAR, THE EYES KEEP CHANGING, THE PATIENT HAS DRY EYE, LIFITEGRAST X 16 WEEKS WAS GIVEN FOR DRY EYES. THE POSSIBLE DRY EYE TREATMENT HAS BEEN TOLD POSSIBLE STRABISMUS ISSUE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT AFTER CATARACT SURGERIES IN EARLY (B)(6) 2024, THE PATIENT BEGAN EXPERIENCING TRAPEZOIDAL DISTORTIONS, WITH OBJECTS APPEARING WIDER AT THE BOTTOM WHEN BOTH EYES ARE OPEN AND FLIPPING DEPENDING ON THE EYE USED. SOON AFTER, EXTREME NAUSEA, DIZZINESS, HEADACHES, EYE STRAIN, AND FATIGUE DEVELOPED, ESPECIALLY WITH NEAR TASKS LIKE READING, TYPING, OR LOOKING AT SCREENS. THESE SYMPTOMS, SIMILAR TO WHAT THEY EXPERIENCED IN THE PAST WITH AN OVERLY STRONG GLASSES PRESCRIPTION, DID NOT IMPROVE WITH ANY OF THE SIX DIFFERENT GLASSES OR CONTACT LENS PRESC

  Patient problems: Blurred Vision; Dizziness; Dry Eye(s); Eye Irritation; Headache; Nausea; Visual Disturbances; Visual Impairment

  MAUDE report 20631987 ↗
• MalfunctionJul 27, 2023Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THAT IOL BROKE INTO 3 PIECES WHEN INSERTED INTO THE EYE. THE SURGERY WAS COMPLETED WITH REPLACEMENT LENS ON SAME PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405389 ↗
• MalfunctionJun 14, 2023Defective Device; Defective Device

  A NURSE REPORTED THAT THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17123724 ↗
• MalfunctionMar 16, 2023Device Damaged by Another Device; Device Damaged by Another Device

  A PHARMACY EMPLOYEE REPORTED THAT THE IMPLANT WAS NOT PLACED DUE TO A DEFECTIVE INJECTOR, WHICH DAMAGED THE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 16552424 ↗
• MalfunctionJan 19, 2023Defective Device; Defective Device

  A NURSE REPORTED THAT A LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16206069 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAIN OF LOSS OF VISION. THE PATIENT DIAGNOSED WITH ENDOPHTHALMITIS. ON ULTRASOUND SONOGRAPHY (USG), IT WAS NOT POSTERIOR BUT AROUND THE IOL. SURGEON HAS STARTED MEDICAL TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THE IOL HAS NOT BEEN EXPLANTED AND SURGEON REVEALED IT WAS NOT INFECTION BUT INFLAMMATION AROUND THE IOL. AFTER SUDDEN VISION LOSS PATIENT STARTED WITH INTRAVITREAL GLYCOPEPTIDE ANTIBIOTICS + CEPHALOSPORINS AND TOPICAL MEDICATION. PATIENT ALSO STARTED WITH SYSTEMIC STEROID. THE PATIENT'S ISSUES NOT YET FULLY RESOLVED.

  Patient problems: Endophthalmitis; Visual Impairment

  MAUDE report 14988852 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED RESIDUAL MYOPIA. THE IOL EXCHANGED FOR ANOTHER LENS FORTY-TWO DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12343788 ↗
• MalfunctionMar 18, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED AN INTRAOCULAR LENS (IOL) AS DEFECTIVE ON A RETURN FORM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11515641 ↗