ACRYSOF® ACRYSERT® SN6CWS (REF SN6CWS.220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652249256), received between Nov 7, 2022 and Nov 7, 2022 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE SURGEON HAD DIFFICULTIES IMPLANTING THE LENS, DURING THE SURGERY A VITREOUS HEMORRHAGE OCCURRED AND THE LENS COULD NOT BE PLACED IN THE CAPSULE BAG BUT WAS PLACED IN THE SULCUS. THREE MONTH LATER HE HAS A VISUAL ACUITY OF APPROX. 0.8. AFTER WHICH THERE WAS A RETINAL DETACHMENT THAT WAS OPERATED/TREATED IN ANOTHER HOSPITAL. A VITREOUS ROD WAS PASSED IN THE ANTERIOR CHAMBER AND WAS REMOVED 8 WEEKS LATER WITH THE LASER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING, IT WAS A DIFFICULT CATARACT SURGERY IN A MULTIMORBID PATIENT. THE PATIENT HAD EXPERIENCED FLAT ANTERIOR CHAMBER, BLEEDING INTO ANTERIOR CHAMBER. THE VITREOUS HEMORRHAGE OCCURED DURING THE SURGERY BUT BEFORE THE LENS WAS IMPLANTED. THE PATIENT HAD EXPERIENCED BLEEDING INTO ANTERIOR CHAMBER, VIS A TERGO, VD, CHOROIDAL EFFUSION, EXPULSIVE BLEEDING, POSTERIOR CAPSULAR RUPTURE AND A VITRECTOMY WAS DONE THEN THE LENS WAS INSERTED INTO SULCUS CILIARIS. AS PER THE SURGEON THE FATEFUL COURSE OF THE DISEASE, OR SECOND SURGERY, WHICH BECAME NECESSARY AFTER TYPICAL NW AMOTIO RETINAE HAD CAUSED THE EVENT. THE LENS AFTER IMPLANTED INTO THE SULCU

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Hemorrhage/Blood Loss/Bleeding; Retinal Detachment; Vitreous Detachment; Vitreous Hemorrhage

  MAUDE report 15742037 ↗