ACRYSOF® SN60WF (REF SN60WF.200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00380655093191), received between May 3, 2021 and May 25, 2026 — classified as 15 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT HAD BEEN UNABLE TO READ AND EXPERIENCED DRY EYES. THE PATIENT STATED THAT THEY HAD BEEN GOING BACK AND FORTH GETTING PLUGS INSERTED FOR DRY EYE MANAGEMENT, BUT CONTINUED TO EXPERIENCE SYMPTOMS, DESCRIBING A SENSATION AS IF A SHIELD CAME OVER THEIR EYES, PREVENTING THEM FROM READING MORE THAN ONE OR TWO PAGES. THEY REPORTED HAVING TRIED DIFFERENT PRESCRIPTION LENSES AND GLASSES WITHOUT RELIEF. THE PATIENT ALSO QUESTIONED WHETHER THERE HAD BEEN AN ISSUE WITH THE INTRAOCULAR LENS USED DURING THEIR CATARACT SURGERY IN 2021. THEY EXPRESSED SIGNIFICANT DISTRESS REGARDING THEIR VISION SINCE THE SURGERY AND INDICATED THAT THEY WERE PLANNING TO VISIT THEIR EYE DOCTOR THAT MORNING DUE TO ONGOING PROBLEMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.

  Patient problems: Dry Eye(s)

  MAUDE report 25271626 ↗
• MalfunctionMar 2, 2026Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, A CRACK WAS OBSERVED ON THE IOL. THE SURGEON¿S INITIAL DECISION WAS NOT TO IMPLANT THE LENS. HOWEVER, THE PATIENT SUBSEQUENTLY RUPTURED THE CAPSULE, AND ANOTHER THREE-PIECE LENS WAS IMPLANTED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE SURGERY WAS DONE IN PATIENT'S LEFT EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. THE PATIENT'S SYMPTOMS WERE RESOLVED. THE CAPSULE RUPTURE WAS NOT RELATED TO THE IOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489884 ↗
• MalfunctionDec 19, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN TRYING TO UNFOLD NOTICED THAT OPTICAL-BONDED HAPTIC THAT BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23849971 ↗
• MalfunctionJun 30, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS OPTIC WAS STUCK IN THE INJECTOR PLUNGER TIP, CAUSED THE HAPTIC BROKE. LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22353393 ↗
• MalfunctionMay 19, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED INTO CARTRIDGE FOLDED IN CONCAVE, THE FOLLOWING HAPTIC WAS NOT BENDING INTO CARTRIDGE. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045615 ↗
• MalfunctionDec 26, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT HAPTIC WAS STUCK TO THE OPTIC AFTER IMPLANTING THE LENS. THE SURGEON HAD TO USE CONSIDERABLE FORCE AND EFFORT WITH THE USE 2 UNSPECIFIED INSTRUMENTS TO SEPARATE THE HAPTIC FROM OPTIC. THE HAPTICS EVENTUALLY DETACHED FROM THE OPTIC THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO EFFECT ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019567 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BASED ON THE PATIENT'S BIOMETRY, THE DOCTOR TARGETED A SLIGHTLY MYOPIC REFRACTION WITH A POWER OF 20 D (REF -0.39). AT POST OP, IT WAS FOUND THAT THERE WAS A MYOPIC SURPRISE OF -2.75 D. THE DOCTOR HAD DONE THE BIOMETRY AGAIN, CONFIRMED NO MEASUREMENT ERROR AND SUSPECTED MYOPIC SURPRISE OCCURRED DUE TO A POWER ERROR IN THE LENS. PATIENT ALSO EXPERIENCED BLURRY DISTANCE VISION.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19927070 ↗
• MalfunctionMay 30, 2024Break; Break

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BROKEN IOL DURING HANDLING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19425005 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED ENDOPHTHALMITIS DURING SECOND FOLLOW UP VISIT. THE PATIENT WAS TREATED IMMEDIATELY AND SUCCESSFULLY. THE PATIENT WAS FINE AND STILL FOR FOLLOW UP AND OBSERVATION. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLIANT. THIS REPORT IS 2 OF 5. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING PATIENT WAS HOSPITALIZED, REQUIRED INTRAVITREAL INJECTION OF ANTIBIOTICS AND VITRECTOMY TO PREVENT PERMANENT DAMAGE. LATEST VISUAL ACUITY WAS REPORTED AS LIGHT PERCEPTION.

  Patient problems: Endophthalmitis

  MAUDE report 19124448 ↗
• MalfunctionFeb 21, 2024Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN INJECTING THE LENS INTO THE EYE, HANDPIECE DID NOT DEPLOY THE LENS WENT UNDER THE LENS, CARTRIDGE WAS REMOVED FROM THE HANDPIECE. UPON ENTERING THE EYE HAPTICS WERE CAUGHT ON EACH OTHER. ONCE THE HAPTICS WERE IN PLACE IT WAS NOTED THAT THERE WAS A DEFECT IN THE CENTER OF THE LENS. LENS WAS EXPLANTED IN INITIAL PROCEDURE. SURGEON OPTED TO CUT THE DEFECTIVE LENS OUT AND REPLACE IT WITH A UNSPECIFIED NEW LENS.

  Patient problems: Insufficient Information

  MAUDE report 18746353 ↗
• MalfunctionDec 21, 2023Crack; Crack

  THIS REPORT WAS RECEIVED FROM THE CHINESE HEALTH AUTHORITY VIA NON-HEALTHCARE PROFESSIONAL, REPORTED THA DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE LENS EDGE WAS CRACKED. THE IOL WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18372127 ↗
• MalfunctionNov 20, 2023Defective Device; Device Contamination with Chemical or Other Material; Defective Device; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT THE SURGEON NOTICED AN ANOMALY ON THE SURFACE OF THE LENS WHILE LENS WAS IN THE EYE BAG. THE DOCTOR EXPLAINED THAT IT WAS AN EXTRA MATERIAL LIKE WIRE EXTENDED FROM THE SURFACE OF THE LENS. THE DOCTOR TRIED TO REMOVE IT WITH A FORCEPS AND WITH THE ASPIRATION AND IRRIGATION MODULE, BUT WITH NO RESULT THEN THE SURGEON CUT IT AND REMOVED FROM THE PATIENTS EYE. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18168691 ↗
• InjuryOct 20, 2023Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT A COMPANY LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE IN THE MONTH OF JANUARY & PATIENT COME BACK WITH A COMPLAINT OF BLURRY VISION AND LENS OPACITY. PHYSICIAN ADVISED THE PATIENT TO HAVE THE LENS REMOVED. HE REMOVED THE LENS AND IMPLANTED AN ANOTHER COMPANY LENS IN THE PATIENT'S RIGHT EYE. PHYSICIAN SHARED CONCERNS RELATED TO THE OPACITY OF LENS & HANDED OVER THE EXPLANTED IOL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEFORE LENS EXPLANT, THE PATIENT HAD YAG CAPSULOTOMY.

  Patient problems: Blurred Vision

  MAUDE report 17976716 ↗
• MalfunctionOct 9, 2023Failure to Eject; Failure to Eject

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS STUCK IN CARTRIDGE DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17894487 ↗
• MalfunctionSep 5, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED THERE WAS FLUFF ON THE LENS, WHEN OBSERVED UNDER THE MICROSCOPE, WHICH CANNOT BE REMOVED. HENCE THE LENS WAS CUT AND REMOVED FROM THE EYE AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17687117 ↗
• MalfunctionMay 26, 2023Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT ONE OF THE INJECTORS IS BROKEN. WHEN INSERTED THE LENS, THE LENS DID NOT ESCAPE AND ONE FOOT OF THE LENS BROKE ON THE WAY INTO THE PATIENT'S EYE. THE LENS HAS NOW BEEN REMOVED AND REPLACED WITH A NEW ONE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, COMPANY INJECTOR BROKE THE LENS. THE IOL IS NOT SUSPECTED. ADDITIONAL INFORMATION WILL BE PROVIDED UNDER MANUFACTURER REPORT NUMBER 2523835-2023-00438.

  Patient problems: Insufficient Information

  MAUDE report 17008719 ↗
• InjuryMay 22, 2023Material Opacification; Material Opacification

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT SIGHT LIKE LOOKING THRU A CLOUDED LENS. THE PATIENT EXPERIENCED VISUAL DISTURBANCES SUCH AS GLARE AND RINGS AROUND LIGHTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Retinal Detachment; Visual Disturbances

  MAUDE report 16975568 ↗
• MalfunctionApr 3, 2023Break; Break

  A OTHER HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE HAPTIC WAS BROKEN. THERE WAS NO HARM TO THE PATIENT AND NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED. THE PATIENT SYMPTOMS HAVE RESOLVED. THE LENS WAS CUT AND REMOVED FROM THE EYE IN THE SAME PROCEDURE. THE SURGERY WAS COMPLETED BY USING A REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667637 ↗
• MalfunctionFeb 27, 2023Crack; Crack

  A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS PRESENTED WITH A FISSURE. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16442514 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRA OCULAR PRESSURE HAS GONE UP TO THE POINT THE SURGEON PUT HER ON DROPS TO ALLEVIATE. THE EYE PRESSURE WAS NOT WELL CONTROLLED WITH DROPS, SO SHE HAD ANOTHER LASER, THEN AN OMNI STENT. THE PATIENT IS TAKING PILOCARPINE AND DORZOLAMIDE EYE DROPS. THE PATIENT HAD A HISTORY OF GLAUCOMA. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16336082 ↗
• MalfunctionSep 8, 2022Crack; Scratched Material; Crack; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAS CRACKED. THE IOL WAS IMPLANTED AND REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15377161 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND THE VISION IS LIKE A STRING ACROSS THE LENS. THE LENS WAS IMPLANTED AS A PREVENTIVE MEASURE WITH INTRAOCULAR PRESSURE BY THE SURGEON. THE BLURRY VISION WAS NOT AN ISSUE BEFORE THE PROCEDURE. WHEN THE PATIENT HOLD THE EYE TIGHT OR TAKE AN UNSPECIFIED EYEDROP THE VISION CLEARS. THE VISION THROUGH THE NASAL SIDE OF THE LENS SEEMS LIKE IT IS NOT IN THE RIGHT PLACE. THE LENS FEELS LIKE A FOREIGN OBJECT IS THERE. ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE CONSUMER AND STATED THAT CONSUMER HAD DIPLOPIA ALSO. CONSUMER ALSO STATED THAT, A STENT WAS PLACED TO DECREASE THE IOP (INTRAOCULAR PRESSURE) ON (B)(6) 2021.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Intraocular Pressure Increased; Visual Disturbances

  MAUDE report 15320802 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), UNABLE TO DRIVE AT NIGHT DUE TO BRIGHT LIGHTS. THE PATIENT HAD DULL HALOS AT NIGHT FROM HEADLIGHTS. AFTER DISCUSSING THE SCENARIO WITH ANOTHER PHYSICIAN, HE TOOK OFF SOME LIQUID FROM BEHIND THE LENS IMPLANT FROM BOTH EYES. DUE TO IT DULL HALO IS A VERY BRIGHT BURST. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Halo

  MAUDE report 15248534 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), UNABLE TO DRIVE AT NIGHT DUE TO BRIGHT LIGHTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15092652 ↗
• InjuryMay 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS FOUND TO BE DISLOCATED. THE LENS WAS EXCHANGE WITH ANOTHER IOL IN SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 14410460 ↗