ACRYSOF® SN6AT3 (REF SN6AT3.200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652249898), received between Dec 3, 2021 and Sep 11, 2023 — classified as 4 injuries, 2 malfunctions.

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

• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT HAPPY WITH THE BLURRY VISION WITH REDNESS X MONTH, CLINICAL REASON BEING MECHANICAL COMPLICATION OF LENS LEFT EYE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Hyperemia

  MAUDE report 17718140 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLURRED VISION AND THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 16519897 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION AT DISTANCE ENDED UP -2.00 MYOPIA AND UNSATISFIED REFRACTIVE OUTCOME AFTER SURGERY. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15555494 ↗
• MalfunctionSep 26, 2022Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE IOL WAS INSERTED, THE POST IMPLANTATION MEASUREMENTS KEPT SAYING THAT AMOUNT OF CYL INCREASED DESPITE ROTATING THE LENS ALL 360 DEGREES. THE SURGEON CUT THE IOL OUT AND REMEASURED IT, THE DATA WAS GOOD. THE SURGEON ENDED UP PULLING THE SAME LENS MODEL AND POWER THE SECOND TIME AROUND; AND AT THAT TIME, THE ORA MEASUREMENTS WERE AS EXPECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THE REPLACEMENT LENS WAS OF SAME MODEL, DIOPTER AND THE SURGERY WAS COMPLETED SAME DAY, THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED.

  Patient problems: Visual Impairment

  MAUDE report 15484989 ↗
• InjuryJan 11, 2022Adverse 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 SULCUS CAUSED IRIS CLEFT AND INCREASED IOP. UNABLE TO REPOSITION INTO BAG. THE IOL WAS EXPLANTED WITH ANOTHER IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 13223328 ↗
• MalfunctionDec 3, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A MEDICAL ENGINEER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND OTHER VISUAL SIDE EFFECTS. THE SLIT LAMP IMAGES AND THE PENTACAM IMAGES SHOW GLISTENING'S. DIAGNOSED WITH GLIMMER VISION. THE PATIENT ISSUE WAS NOT RESOLVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Visual Disturbances

  MAUDE report 12927536 ↗