Clareon SY60WF (UDI 00380652251570)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652251570), received between Jul 10, 2022 and Apr 10, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Break

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC OF THE LENS WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24843585 ↗
• MalfunctionMar 24, 2026Scratched Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH ON LENS WAS NOTICED AFTER IT WAS IMPLANTED. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24673718 ↗
• MalfunctionMar 13, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THERE WAS A SEPARATION OF THE HAPTIC ELEMENT WHICH WAS DURING IOL IMPLANTATION. THERE WAS PATIENT CONTACT. NO PATIENT INJURY. THE PLANNED PROCEDURE WAS COMPLETED, THE IOL WAS EXPLANTED AND REPLACED WITH A SIMILAR COMPANY LENS. 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 24590600 ↗
• InjuryAug 1, 2025Adverse 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 UNABLE TO READ. THE PATIENT WAS TOO NEAR SIGHTED AND ASTIGMATISM WAS INCREASED. THE PATIENT VISUAL ACUITY WAS WORSE THAN BEFORE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22685823 ↗
• MalfunctionJun 18, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT ONE OF THE PRELOADED WAS MISSING THE IMPLANT, ONE HAPTIC WAS MESSED UP. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE HAPTIC CAME OUT STRAIGHT/TWISTED. IT WAS ALSO STATED THAT THERE WAS NO PATIENT CONTACT TO THE DEVICE. THERE ARE 3 FILES ASSOCIATED WITH THIS COMPLAINT. THIS FILE BELONGS TO 3 OF 3.

  Patient problems: Insufficient Information

  MAUDE report 22285912 ↗
• MalfunctionJun 5, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, TWISTED LEG (HAPTIC). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150868 ↗
• MalfunctionMay 8, 2025Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A LARGE GORGE IN THE MIDDLE OF THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS FOUND SCRATCHED UPON INJECTION AND WAS CUT OUT AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986449 ↗
• MalfunctionApr 23, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE EVENT OCCURRED DURING LOADING OF LENS. THERE WAS NO PATIENT CONTACT. THE SURGERY COMPLETED WITH REPLACEMENT LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891579 ↗
• MalfunctionMar 26, 2025Failure to Fold; Material Split, Cut or Torn; Failure to Fold; Material Split, Cut or Torn

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS CRACKED, IT WAS NOT FOLDING PROPER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695524 ↗
• MalfunctionMar 20, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED TWO DIFFERENT INCIDENTS DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT ADVANCE OR EJECT. THE HAPTIC WAS BENT OR CRIMPLED OR TWISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 2 OF 2 FILES.

  Patient problems: Insufficient Information

  MAUDE report 21652110 ↗
• MalfunctionMar 11, 2025Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS FOUND TO BE SCRATCHED AFTER IMPLANTATION. THERE WAS NO PATIENT HARM. LENS WAS EXPLANTED IN INITIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574468 ↗
• MalfunctionFeb 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A CRACK ACROSS OPTIC AND JUNCTION. THE LENS WAS BROKEN AT ONE OF THE HAPTICS. THE LENS WAS INSERTED AND REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21457459 ↗
• MalfunctionFeb 18, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS ALL CURLED UP AND HAD MARKS ON IT WHEN HE LOOKED AT IT UNDER THE MICROSCOPE. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393447 ↗
• MalfunctionJan 27, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, HAPTIC WAS BROKEN AFTER LENS IMPLANTED INSIDE THE EYE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH COMPANY ANOTHER MODEL LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241427 ↗
• MalfunctionJun 12, 2024Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THERE WAS AN OPACIFICATION ON THE LENS SURFACE AFTER IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19517950 ↗
• MalfunctionApr 12, 2024Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS SCRATCHED AFTER IMPLANTING THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE IS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095905 ↗
• MalfunctionJan 8, 2024Scratched Material; Scratched Material

  A NURSE REPORTED THAT LENS DEFECTIVE NOTED UPON IMPLANTATION DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. LENS WAS EXPLANTED AT INITIAL PROCEDURE. REPLACED WITH UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AS LENS WAS DAMAGED UPON INSERTION, HAD SCRATCHES. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464110 ↗
• MalfunctionAug 28, 2023Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED THAT THE PLUNGER WENT UNDERNEATH THE LENS AND THAT THERE WAS A LARGE CRACK IN THE MIDDLE OF THE LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IN THE SURGEON'S OPINION, THE PLUNGER WAS NOTED TO BE BENEATH THE LENS AT THE TIME OF INSERTION CAUSED THE EVENT. AFTER THE IMPLANTATION, THE LENS WAS CUT IN THE HALF WITH THE SCISSORS AND REMOVED AND ANOTHER LENS OF SAME MODEL WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 17630593 ↗
• MalfunctionApr 14, 2023Crack; Crack

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CRACK WAS NOTED IN THE OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THERE WAS NO CARTRIDGE ISSUE, THERE WAS NO ISSUE WITH INJECTOR, THE LENS TOUCHED THE EYE, BUT THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742019 ↗
• MalfunctionJul 10, 2022Scratched Material; Scratched Material

  A PURCHASING MANAGER REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT, THE LENS HAD A SCRATCH ON IT. THERE WAS PATIENT CONTACT. SURGERY WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14973771 ↗