ACRYSOF® SN6AT4 (REF SN6AT4.200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652250429), received between Aug 18, 2021 and Apr 15, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Break

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, AFTER IMPLANTING THE INTRAOCULAR LENS (IOL) INTO THE BAG OF THE PATIENT¿S RIGHT EYE, ONE OF THE IOL HAPTICS BROKE INSIDE THE EYE. THE DAMAGED LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH ANOTHER LENS OF THE SAME MODEL BUT WITH DIFFERENT TORICITY AND AN ADDITIONAL 0.5 DIOPTER OF POWER. A WIDENING OF THE MAIN INCISION WAS NEEDED FROM 2.2 TO 2.75MM. THERE WAS NO FURTHER IMPACT TO THE PATIENT. ACCORDING TO THE SURGEON, THE INJECTOR WAS NOT THE CAUSE OF THE ISSUE, AS OTHER IMPLANTATIONS WERE PERFORMED IN THE SAME DAY AFTER STERILIZATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Eye Injury

  MAUDE report 24884557 ↗
• MalfunctionAug 4, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE LOADING THE LENS THE HAPTIC WAS BROKEN. THE IOL WAS NOT IN PROPER POSITION TO IMPLANT IN THE CAPSULAR BAG· THE SURGERY WAS COMPLETED WITH BACK UP REPLACEMENT LENS ON THE SAME DAY· ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699737 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. CLINICAL REASON FOR EXPLANT HIGHER POWER TORIC IOL. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL COMPANY LENS 2 MONTHS 6 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21363380 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT APPROXIMATELY 9 YEARS AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING A LOT OF ALLERGIES AND NOTICED A CHANGED IN HER VISION. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND RECEIVED UNSPECIFIED ALLERGY MEDICATIONS BUT HAD NOT SEEN ANY IMPROVEMENT IN HER VISION. THE PATIENT DECIDED THAT SHE WOULD SEE AN EYE CARE PROFESSIONAL (ECP) ABOUT HER ISSUES AND FOR AN OVERALL EXAM. SHE CANNOT TELL IF BLURRY VISION WAS IN BOTH EYES (OU), OR JUST ONE EYE. SHE ONLY HAD AN IMPLANT CARD FOR 1 EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Hypersensitivity/Allergic reaction

  MAUDE report 18839302 ↗
• MalfunctionJun 15, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT AFTER IMPLANTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, IT WAS FOUND THAT THERE WERE SEDIMENT ON THE HAPTIC, WHICH THE SURGEON COULD NOT REMOVE EVEN WITH SURGICAL INSTRUMENTS. THE SURGEON CONSIDERED IT TO BE ON THE HAPTIC AND DID NOT REMOVE IT, BUT WAS CONCERNED THAT IT WOULD HAVE AN IMPACT ON THE PATIENT IN THE FUTURE.

  Patient problems: Insufficient Information

  MAUDE report 17135664 ↗
• MalfunctionDec 15, 2022Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A LENS WAS SCRATCHED NOTED. ADDITIONAL INFORMATION RECEIVED STATING THERE WAS NO PATIENT IMPACT. THE CASE WAS COMPLETED THE SAME DAY WITH A NEW LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988878 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTH CARE PROFESSIONAL REPORTED THAT LENS WAS EXPLANTED AS PATIENT WAS UNHAPPY WITH THE NEAR VISION AND THE CLINICAL REASON WAS SLIGHTLY HYPEROPIC TO 215 REFRACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15425588 ↗
• MalfunctionMay 27, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A PHARMACIST REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT UNFOLD PROPERLY. THE PROCEDURE WAS COMPLETED USING BACK UP LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14520633 ↗
• InjuryOct 15, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON INSERTED THE LENS INTO THE EYE AND CAUSED THE BAG TO BREAK. THE IOL WAS REMOVED AND REPLACED WITH A BACKUP LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 12637914 ↗
• MalfunctionAug 18, 2021Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED VIA RETURN FORM THAT LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338778 ↗