ACRYSOF® SN60WF (REF SN60WF.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00380655093214), received between Mar 1, 2021 and Aug 13, 2026 — classified as 17 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  A report was received from the health authority and reported following an intraocular lens (IOL) implant procedure, the patient experienced hypersensitive to light both indoor lighting and especially sunlight. The patient experienced these after her cataract surgery in 2022. When the patient was outdoors, she wears sunglasses fitted by an optician with wide temples and they do not help. In (b)(6) 2026, she visited an optician and according to the doctor there was nothing wrong with her eyes. After spending time outdoors, her eyes became extremely strained and afterward she had difficulty focusing on vision. The areas around her eyes become red and swollen and her eyes look tired and overworked. She becomes very fatigued and develops headaches, she cannot stay outdoors on a sunny day and becomes extremely tired. Patient feels that her life was limited by light sensitive eyes. Before the cataract surgery, she did not have these problems.Additional information was received and stated, patient was informed that the light sensitivity would improve after 6 weeks of surgery. However, she had experienced light sensitivity ever since and it was difficult to be outdoors in sunlight and dazzl

  Patient problems: Blurred Vision; Eye Pain; Headache; Visual Disturbances

  MAUDE report 50234568 ↗
• MalfunctionMay 11, 2026Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC BROKEN DURING INJECTION OF IOL. IT WAS STATED THAT PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE INITIAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137115 ↗
• MalfunctionApr 2, 2026Break

  A CUSTOMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING THE ASSEMBLY OF THE IOL IN A CARTRIDGE, ONE HAPTIC COIL OF THE IOL WAS AMPUTATED DURING PROGRESSION IN THE INJECTOR ADVANCEMENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. THERE WERE NO PATIENT CONTACT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761700 ↗
• MalfunctionJan 8, 2026Failure to Deliver

  A NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL BECAME STUCK IN THE INJECTOR TIP. THERE WAS PATIENT CONTACT, BUT NO PATIENT HARM OCCURRED. THE SURGERY WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003572 ↗
• MalfunctionJan 2, 2026Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS FOUND TO BE SEPARATED FROM THE LENS. THE LENS WAS NOT USED, AND THE PATIENT WAS IMPLANTED WITH SAME POWER LENS ON THE SAME DAY. THE PATIENT WAS UNAWARE OF THE LENS BREAKAGE.

  Patient problems: Insufficient Information

  MAUDE report 23945316 ↗
• MalfunctionJan 2, 2026Material Twisted/Bent

  A NURSE REPORTED THAT DURING PROCEDURE THE LENS OPENED DURING THE IMPLANTATION STAGE, UNDER THE MICROSCOPE, IT WAS OBSERVED THAT THE POSTERIOR HAPTIC PART OF THE LENS PLACED INTO THE COMPANY INJECTOR AND CARTRIDGE WAS ADHERENT. THE SURGERY WAS COMPLETED WITH ANOTHER LENS OF THE SAME DIOPTER. THERE WAS NO PATIENT CONTACT AND HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT ADHESIONS WERE DETECTED UNDER THE MICROSCOPE, AND INSTEAD OF APPLYING THE PRODUCT, A LENS CHANGE WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943464 ↗
• MalfunctionDec 12, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC DAMAGED AT IMPLANT INJECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THE IOL WAS IMPLANTED AND EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT IMPACT. THE PATIENT CURRENTLY RECOVERED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790733 ↗
• InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, THE INTRA OCULAR LENS (IOL) IMPLANTED IN 2007 IN THE LEFT EYE HAD SLIPPED OUT OF ITS POSITION. A STABILIZATION RING WAS IMPLANTED IN THE STRABISMUS TREATMENT. IOL DISLOCATED FOR APPROXIMATELY 8 YEARS AND SINCE THEN DOUBLE VISION FLUCTUATED IN INTENSITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Dry Eye(s); Visual Disturbances; Visual Impairment; Vitreous Detachment

  MAUDE report 22307259 ↗
• MalfunctionJun 13, 2025Failure to Deliver; Failure to Deliver

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS DID NOT DEPLOY CORRECTLY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED LENS FAILED WHEN ATTEMPTING TO DEPLOY, THE LENS HAD CONTACT WITH PATIENT, LOADER INSERTED, LENS WOULD NOT DEPLOY, LOADER AND LENS REMOVED. UNSPECIFIED LENS OPENED AND INSERTED WITHOUT PROBLEMS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203204 ↗
• MalfunctionJun 5, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE SURGEON NOTICED DEFECTIVE HAPTIC. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150839 ↗
• MalfunctionMay 12, 2025Break; Break

  A REPORT RECEIVED VIA ADMINISTRATOR/SUPERVISOR FROM THE CHINESE HEALTH AUTHORITY STATING THAT BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN PREPARING FOR IMPLANTATION, IT WAS FOUND THAT THE HAPTIC WAS BROKE WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT WITH A NEW IOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004140 ↗
• MalfunctionMay 8, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING INJECTION INTO THE EYE LENS DISTAL LOOP BROKEN AND IT DID NOT FULLY ENTERED INTO THE EYE. SO, THE LENS WAS EXTRACTED AND REPLACED WITH ANOTHER UNSPECIFIED LENS OF THE SAME POWER DURING THE INITIAL PROCEDURE WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984869 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED ABOUT THAT DURING INTRAOCULAR LENS IMPLANTATION PROCEDURE, THE PATIENT SUFFERED A CAPSULAR RUPTURE. THE IMPLANTED LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 21036263 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE PATIENT POSTERIOR CAPSULE RUPTURED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH BACKUP SULCUS LENS AS REPLACEMENT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 20757897 ↗
• MalfunctionNov 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE PROFESSIONAL REPORTED, THAT BEFORE CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THERE WAS A CRACK IN LENS, NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20612859 ↗
• MalfunctionOct 14, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION OF THE IOL BY SURGEON THE LENS WAS NOT UNFOLDING INSIDE THE EYE. SURGEON HAD TO EXPLANT THE IOL AND IMPLANT WITH OTHER DIOPTER AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20446318 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS RECEIVED FROM THE CHINA LOCAL HA SYSTEM REGARDING A PATIENT WHO UNDERWENT INTRAOCULAR LENS IMPLANTATION IN HIS LEFT EYE ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S SUSPENSORY LIGAMENT WAS LOOSE, THE POSTERIOR CAPSULE HAD RUPTURED, AND THE INTRAOCULAR LENS HAD FALLEN AND COULD NOT BE POSITIONED. THE LENS WAS CUT OPEN AND REMOVED, AND A COMPANY INTRAOCULAR LENS WAS IMMEDIATELY PLACED IN THE CILIARY SULCUS AND STABILIZED. IT DID NOT ENTER THE VITREOUS CAVITY OR CAUSE ANY HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 20022304 ↗
• InjuryApr 18, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A COMPLICATION HAPPENED UPON DELIVERY OF THE LENS. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT UPON DELIVERY OF LENS POSTERIOR CAPSULE RUPTURED AND LENS DAMAGED. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING SAME PROCEDURE.

  Patient problems: Capsular Bag Tear

  MAUDE report 19132118 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED FLASHES AND LIGHT LIKE A FLAME. THE SYMPTOMS WERE WORSENING DAY BY DAY AND NO FINDINGS HAS BEEN FOUND IN EXAMINATION. THE PATIENT FELT LIKE MILLION OF FLASHES AND LIGHTENING ALL DAY WHICH STOPS UPON CLOSING THE EYES. THE SYMPTOMS WERE CONTINUING. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT SYMPTOMS AFTER MORE THAN 1 MONTH OF SURGERY WERE CONSTANTLY PRESENT WITH THE SAME INTENSITY.

  Patient problems: Corneal Edema; Flashers; Inflammation; Visual Disturbances

  MAUDE report 18473627 ↗
• MalfunctionOct 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, IT WAS NOTICED THAT THE LENS WAS TORN. THUS, IT WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18019871 ↗
• InjurySep 21, 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 EXPERIENCED SYMPTOMS OF DYSPHOTOPSIA , STARBURSTS , PERCEPTUAL DISTORTION , PELOPSIA. PATIENT EXPRESSED THE SYMPTOMS TO THE SURGEON AND SURGEON ADVISED TO WAIT TILL THE SYMPTOMS ADJUST. BUT THE SYMPTOMS WERE NOT DISAPPEARED AND HAD BECOME SEVERELY BOTHERSOME OVER TIME. THE PATIENT WAS EXPERIENCING ONGOING LOSS OF BALANCE AND DIZZINESS DUE TO THE CHRONIC PELOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE (OS).

  Patient problems: Dizziness; Visual Disturbances

  MAUDE report 17787177 ↗
• MalfunctionJun 1, 2023Defective Device; Defective Device

  A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS COULD NOT BE PLACED IN THE PATIENT SINCE IT WAS VERY RIGID, SEVERAL ATTEMPTS WERE MADE TO IMPLANT INTO THE EYE AND WERE UNSUCCESSFUL. IT WAS CONTAMINATED SINCE IT TOUCHED THE PATIENT'S EYE. A BACK UP LENS WAS USED AND WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036823 ↗
• MalfunctionMay 23, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS UNFOLDING INCORRECTLY WHEN TRYING TO ADVANCE LENS INTO THE EYE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16982104 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLURRY VISION AS HE WAS NOT ABLE TO SEE TO WATCH TELEVISION AND CANNOT DRIVE. CLOSES THE RIGHT EYE TO DRIVE. WAS TOLD TO WEAR GLASSES FOR DISTANCE AND THEY DID NOT HELP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16863220 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A BACK UP LENS.

  Patient problems: Rupture

  MAUDE report 16822217 ↗