ACRYSOF® SA60WF (REF SA60WF.190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652332644), received between Mar 15, 2021 and Apr 6, 2026 — classified as 2 injuries, 8 malfunctions.

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

• MalfunctionApr 6, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN WHEN THE IOL WAS BEING LOADED WITH NO PATIENT CONTACT AND NO PATIENT HARM. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH ANOTHER REPLACEMENT LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789801 ↗
• MalfunctionDec 4, 2025Break; Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE IT WAS OBSERVED THAT THE HAPTIC BROKEN/TORN/MISSING. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23716969 ↗
• MalfunctionJul 16, 2025Material Twisted/Bent; Material Twisted/Bent

  A NURSE REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE, THE PHYSICIAN OBSERVED AN ADDITIONAL PIECE OF HAPTIC ATTACHED TO ONE OF THE TWO HAPTICS. THE PHYSICIAN DECIDED NOT TO EXPLANT THE IOL AS IT APPEARED WELL-CENTERED IN THE CAPSULAR BAG AND WAS NOT EXPECTED TO CAUSE ANY ISSUES. THE SURGERY WAS COMPLETED SMOOTHLY, AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518234 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER INTRAOCULAR LENS IOL) IMPLANTATION, SHE HAD THE IMPRESSION THAT SOMETHING WAS WRONG WITH THE IMPLANTED LENS - DEPENDING ON WHICH SIDE THE ARTIFICIAL LIGHT FELL FROM, SHE COULD SEE A BAR OF LIGHT, AS IF THE LIGHT WAS REFRACTED ON SOME ELEMENT OF THE LENS. SHE REPORTED THE MATTER TO THE DOCTOR AND THE DECISION WAS MADE TO ROTATE THE LENS BY 90 DEGREES ANGLE. AFTER THAT SHE COULD SEE THE BAR OF LIGHT SLIGHTLY SHIFTED FROM THE PREVIOUS LENS POSITION. SHE REPORTED THAT SHE DID NOT HAVE SUCH SYMPTOMS DURING THE DAY; THIS ONLY APPLIED TO ARTIFICIAL LIGHTING. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 19212183 ↗
• MalfunctionJun 27, 2022Material Opacification; Device Contamination with Chemical or Other Material; Material Opacification; Device Contamination with Chemical or Other Material

  A NURSE REPORTED AN INTRAOCULAR LENS (IOL) WITH A DESCRIPTION OF, IOL HAD A DEPOSITS NOTED WITHIN LENS MATERIAL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14826011 ↗
• MalfunctionNov 9, 2021Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT RIGHT AFTER IMPLANTING THE INTRA OCULAR LENS (IOL), THE SURGEON SAW A SCRATCH IN THE FRONT/ MIDDLE OF THE LENS. ACCORDING TO THE SURGEON IT WAS A NORMAL FOLDING OF THE LENS, PERFORMED BY AN EXPERIENCED NURSE WITH A STANDARD FORCEPS. AT THE TIME OF REPORT THE PATIENT HAD 20/20 VISION AND PATIENT EXPERIENCED A SHADOW WHEN HOLDS HER HAND FOR THE OTHER EYE, HAVE SOME NIGHT DISTURBANCES SYMPTOMS AND SLIGHT GLARE NUISANCE IN THE EVENING. THE DOCTOR CONSIDER TO EXPLANT THE LENS AND THE PATIENT HAS NO SEVERE PROBLEMS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 12780235 ↗
• MalfunctionSep 21, 2021Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE A CRACK IN THE CENTER OF THE IMPLANTED LENS OBSERVED. LENS WAS REMOVED ON THE SAME DAY AND PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12506130 ↗
• MalfunctionSep 6, 2021Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT JAMMED IN THE CARTRIDGE. THERE WAS PATIENT CONTACT WITH THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12428635 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL DID NOT SEAT WELL; THEREFORE, IT WAS REMOVED. A VITRECTOMY WAS DONE AND AN ANTERIOR CHAMBER IOL WAS IMPLANTED. THE PROCEDURE WAS COMPLETED. THE PATIENT DID WELL.

  Patient problems: Insufficient Information

  MAUDE report 11754016 ↗
• MalfunctionMar 15, 2021Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION PROCEDURE, THE IOL BROKE IN HALF FOLLOWING INSERTION OF THE LENS IN THE EYE. THE LENS WAS REPLACE AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483409 ↗