Clareon SY60WF (UDI 00380652251488)Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00380652251488), received between Sep 24, 2021 and Sep 25, 2026 — classified as 5 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (17 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Deformation

  A non-healthcare professional reported that, during an intraocular lens (IOL) implantation procedure, an unknown issue was observed with the lens, and the lens was subsequently discarded.Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50896947 ↗
• MalfunctionSep 17, 2026Break

  A physician reported that during an intraocular lens (IOL) implantation procedure, upon implantation of lens, haptic was found to be broken inside the cartridge. The IOL was subsequently removed and replaced for an unknown replacement lens during initial implantation procedure and procedure was completed on the same day. Additional information has been requested but is not available at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800243 ↗
• MalfunctionJun 9, 2026Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, WHILE LOADING THE LENS INTO THE CARTRIDGE, THE HAPTIC WAS FOUND TO BE BROKEN. THE SURGEON DECIDED TO USE AN UNSPECIFIED COMPANY BACKUP LENS, AND THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25442606 ↗
• MalfunctionMay 25, 2026Break; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION PROCEDURE, IT WAS OBSERVED THAT THE LENS OPTIC AND HAPTIC WERE TORN, AND THE LENS WAS UNSTABLE AFTER IMPLANTATION, REQUIRING EXPLANTATION. THE IMPLANTED LENS WAS EXPLANTED DURING THE SAME PROCEDURE, AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25271695 ↗
• MalfunctionMay 5, 2026Material Deformation

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A GLISTENING IN THE IOL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083457 ↗
• MalfunctionApr 27, 2026Material Deformation

  A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF MARKED OUT AS DAMAGED, NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 25001141 ↗
• MalfunctionApr 27, 2026Failure to Deliver

  A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS GOT STUCK IN THE INSERTER. IT WAS REPORTED THAT THE INCISION WAS ALREADY MADE IN THE PATIENT'S LEFT EYE. THE INITIAL PROCEDURE WAS COMPLETED ON THE SAME DAY USING A COMPANY PROVIDED REPLACEMENT LENS WITH SAME MODEL AND DIOPTER VALUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999683 ↗
• MalfunctionApr 10, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED VIA REPLY CARD THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS DEFECTIVE AND IT WAS WASTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24839109 ↗
• MalfunctionApr 6, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A TORN OR BROKEN HAPTIC WAS OBSERVED; THE HAPTIC WAS SPLIT FROM THE OPTIC. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS PATIENT CONTACT WITH THE ORIGINAL LENS. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE PROCEDURE PERFORMED WAS CATARACT SURGERY WITH IOL IMPLANTATION IN PATIENT¿S RIGHT EYE. THE SURGERY WAS COMPLETED BY REMOVING THE ORIGINAL LENS AND REPLACING IT WITH A NEW LENS IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791477 ↗
• MalfunctionMar 31, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS NOT TWISTED AND COULD NOT BE LOADED OR FOLDED. THE INITIAL PROCEDURE WAS COMPLETED ON THE SAME DAY, AND NO PATIENT CONTACT OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743195 ↗
• MalfunctionMar 25, 2026Break

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS DEFECTIVE AND IT WAS WASTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE HAPTIC WAS NOT ATTACHED TO THE LENS AFTER INSERTION INTO THE EYE, AND THE SURGERY WAS COMPLETED ON THE SAME DAY BY REMOVING THE LENS AND REPLACING IT WITH ANOTHER LENS DURING THE SAME PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24684670 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED INTERMITTENT INFLAMMATION AND GLARE IN THE RIGHT EYE FOLLOWING CATARACT SURGERY ON 25-JUL-2024. HE HAS A HISTORY OF DRY EYE AND FOREIGN BODY SENSATION PRIOR TO SURGERY, WHICH WORSENED POSTOPERATIVELY. HE IS CURRENTLY USING A TOPICAL IMMUNOMODULATOR/CALCINEURIN INHIBITOR TWICE DAILY AND A TOPICAL CORTICOSTEROID FOUR TIMES DAILY AS NEEDED FOR INFLAMMATION AND DRY EYE; THE LAST USE OF THE CORTICOSTEROID WAS ON (B)(6) 2026. HE ALSO USES OVER-THE-COUNTER LUBRICATING/ARTIFICIAL TEARS THROUGHOUT THE DAY. HIS SYMPTOMS HAVE SLIGHTLY IMPROVED, BUT HE WANTED TO HAVE THE LENS EVALUATED TO ¿CROSS IT OFF THE LIST.¿

  Patient problems: Dry Eye(s); Inflammation; Visual Disturbances

  MAUDE report 24672611 ↗
• MalfunctionJan 29, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR REPORTED THAT THE LENS WAS NOT SITTING RIGHT. IN THE SURGEON¿S OPINION, THE HAPTICS WAS CROOKED THAT CONTRIBUTE TO OR CAUSE THE EVENT AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207424 ↗
• MalfunctionDec 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 23907934 ↗
• MalfunctionDec 29, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTICED SCRATCHED LENS IN DELIVERY SYSTEM AND LEFT INTRAOCULAR LENS (IOL) IN PLACE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23906179 ↗
• MalfunctionDec 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR HAD NOTICED A CRACK UNDER THE MICROSCOPE BEFORE IMPLANTATION OF THE IOL. THE PROCEDURE WAS COMPLETED USING ANOTHER UNSPECIFIED LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790739 ↗
• MalfunctionNov 28, 2025Device Damaged by Another Device; Device Damaged by Another Device

  AN ACCOUNT MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT THE LENS WAS USED BUT WAS SCRATCHED BY THE INSTRUMENTS WHEN PLACED INTO THE EYE SO IT WAS REMOVED AND ANOTHER LENS WAS IMPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23671496 ↗
• MalfunctionNov 10, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE HAPTIC FOUND TO BE BROKEN. THE PROCEDURE HAS BEEN COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23510749 ↗
• MalfunctionOct 24, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WOULD NOT LOAD PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23379371 ↗
• MalfunctionAug 13, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS ABSENCE OF PART OF THE HAPTIC AND THE LENS REMAINS IMPLANTED WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801417 ↗
• MalfunctionAug 13, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED WITH DESCRIPTION THAT THE INTRAOCULAR LENS (IOL) APPARENTLY HAD SCRATCHES IN ITS OPTICAL ZONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22792519 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT A MALE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS AND PRESENTED WITH LIGHT PERCEPTION ONLY (VERY LIMITED VISION) WITH VISUAL ACUITY CHANGED TO 20/50, PAIN, CONJUNCTIVITIS, VITRITIS AND HYPOPYON IN THE RIGHT EYE ALONG WITH THE PRESENCE OF AQUEOUS CELL AND AQUEOUS FIBRIN POST FOURTEEN DAYS FROM UNCOMPLICATED PHACOEMULSIFICATION SURGERY WITH IOL PROCEDURE. PRE-OPERATIVE MEDICATIONS WERE GIVEN TO PERFORM SURGERY ASEPTICALLY AND WOUND INTEGRITY WAS FOUND TO BE INTACT AFTER PERFORMING SEIDEL TEST POST COMPLETION OF SURGERY. A CULTURE WAS PERFORMED WITH NO GROWTH. ANTERIOR CHAMBER TAP WAS PERFORMED ALONG WITH INTRAVITREAL ANTIBIOTICS INJECTION BUT IT WAS NOT EFFECTIVE. POST OPERATIVE STEROID, ANTIBIOTIC AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAID) WERE PRESCRIBED AND THE PATIENT IS UNDER MONITORING. CURRENT STATUS OF THE PATIENT IS SYMPTOMS CONTINUING. THIS COMPLAINT IS PERTAINING TO ONE OF THE TWO PATIENTS REPORTED WITH POST OPERATIVE INFECTIONS FROM THE FACILITY.

  Patient problems: Blurred Vision; Conjunctivitis; Endophthalmitis; Eye Pain; Hypopyon; Inflammation; Iritis

  MAUDE report 22688635 ↗
• InjuryJul 30, 2025Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION PRIOR TO IOL IMPLANTATION THE LENS WAS OPENED AND A DROP OF COMPANY VISCOELASTIC WAS APPLIED ON THE OPTIC. THE LENS WAS LOADED USING A COMPANY INJECTOR AND CARTRIDGE AND PROCEED WITH LENS DELIVERY. THE SURGEON NOTICED A SCRATCH AT THE MIDDLE OF THE OPTIC IN PATIENT¿S EYE. AS A RESULT, THE SURGEON HAD TO ENLARGE THE SURGICAL WOUND TO REMOVE THE SCRATCHED LENS AND REPLACE IT WITH A NEW BACKUP LENS WITH ANOTHER UNIT OF COMPANY INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Injury; Insufficient Information

  MAUDE report 22665117 ↗
• MalfunctionJul 21, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED DURING CATARACT INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE OBSERVED THAT ONE SIDE OF THE IOL HAPTIC WAS MISSING. THE PHYSICIAN DECIDED TO CHANGE TO ANOTHER LENS AND THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553912 ↗
• MalfunctionJul 15, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON- HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TECH WAS LOADING LENS AND LENS WAS PARTIALLY INSERTED, THEN THE PHYSICIAN DECIDED TO PULL THE LENS OUT OF THE CARTRIDGE FOR EXAMINATION AND FOUND LENS HAD A KINK IN IT. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509549 ↗