ACRYSOF® ACRYSERT® SN6CWS (REF SN6CWS.235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652249287), received between Apr 16, 2021 and Jun 13, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2022Crack; Crack

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CRACK WAS FOUND ON IOL OPTIC AFTER IMPLANTED IN THE PATIENT'S EYE, THEN REMOVED. THE SURGERY WAS COMPLETED AFTER A NEW REPLACEMENT WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14674209 ↗
• MalfunctionMay 17, 2022Device Damaged by Another Device; Device Damaged by Another Device

  THE REPORT WAS RECEIVED FROM THE HEALTH AUTHORITY AGENCY AND REPORTED THAT, DURING IMPLANTATION OF IOL (INTRAOCULAR LENS), THE RESISTANCE OF THE IOL WAS FOUND TO BE LARGE DURING INJECTION, AND IT WAS FOUND THAT THE EDGE OF THE OPTICAL SURFACE WAS FRIZZY AND UNEVEN UNDER THE MICROSCOPE AFTER IT WAS IMPLANTED INTO THE EYE. NO SPECIAL TREATMENT DUE TO NO OTHER EXCEPTIONS. ON (B)(6) 2022, THERE WAS NO ABNORMAL VISION OR ABNORMAL INFLUENCE ON VISUAL QUALITY WAS FOUND IN THE VISUAL INSPECTION OF THE PATIENT. ON (B)(6) 2022, THE PATIENT'S VISION WAS AT 0.5, CORRECTED PLANO (PL) WAS AT 0.5, AND WAS DISCHARGED AS NORMAL. NO ABNORMAL WAS FOUND WHEN THE PATIENT CAME TO THE HOSPITAL FOR RE-EXAMINATION ON (B)(6) 2022 AND (B)(6) 2022. NO MORE INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14424553 ↗
• MalfunctionMay 5, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THERE WAS CREASE ON OPTIC FOUND IN EYE WHEN VIEWED UNDER MICROSCOPE. THE SURGEON REMOVED THE LENS FROM THE EYE WITHOUT ANY PATIENT HARM DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285343 ↗
• MalfunctionApr 16, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON NOTICED BLACK LINT WAS STUCK TO THE LENS AS HE WAS ABOUT TO IMPLANT THE LENS. THE DEVICE TOUCHED THE PATIENT BUT THE SURGEON WAS ABLE TO REMOVE THE LINT BEFORE IMPLANTING THE LENS. THE LENS WAS IMPLANTED WITH NO FURTHER COMPLICATIONS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11677715 ↗