Clareon SY60WF (UDI 00380652251587)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652251587), received between Jan 18, 2023 and Apr 28, 2026 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Scratched Material

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SET IN THE INJECTOR AS USUAL AND INSERTED INTO THE EYE, BUT SCRATCHES AND DAMAGE WAS FOUND ON THE INTRAOCULAR LENS. AT THAT TIME, NO HEALTH RISKS HAVE BEEN DETERMINED FROM THE SURGERY. THE SURGERY WAS COMPLETED WITH THE LENS STILL FIXED IN THE BAG. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25018498 ↗
• MalfunctionFeb 27, 2026Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, AFTER THE LENS WAS INSERTED INTO THE PATIENT¿S EYE, ONE HAPTIC WAS FOUND TO BE BROKEN. THE LENS REMAINED IMPLANTED, AND THE DETACHED HAPTIC FRAGMENT WAS REMOVED. THE UPPER PORTION OF THE HAPTIC REMAINED ATTACHED TO THE OPTIC. THE REMAINING HAPTIC STUMP UNFOLDED. THE REMAINING HAPTIC WAS STILL OF SUFFICIENT LENGTH, AND THE OPTIC WAS WELL CENTERED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CLINICAL CONSEQUENCES. 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 24470189 ↗
• MalfunctionFeb 23, 2026Material Split, Cut or Torn

  A PHARMACIST REPORTED THAT THE IMPLANT BROKE DURING FOLDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 4.

  Patient problems: Insufficient Information

  MAUDE report 24413671 ↗
• MalfunctionJan 2, 2026Break

  A ACCOUNT MANAGER REPORTED WITH A DESCRIPTION OF HAPTIC BROKE OFF INSIDE THE EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23943737 ↗
• MalfunctionNov 5, 2025Material Twisted/Bent; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAPTIC WAS DEFORMED/ASYMMETRIC. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23475901 ↗
• MalfunctionOct 17, 2025Scratched Material; Scratched Material

  A NURSE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE SCRATCHED. THE PATIENT INTRAOCULAR LENS PRESSURE WAS HIGH SO THE SURGEON TRIED RELOAD TWICE. LENS WASTED. THERE WAS PATIENT CONTACT. IT WAS STATED THAT THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23323087 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REDNESS AND INFLAMMATION WHICH WAS TREATED WITH STEROIDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 3 OF 3 FILES.

  Patient problems: Inflammation; Red Eye(s)

  MAUDE report 22936125 ↗
• MalfunctionJul 9, 2025Failure to Deliver; Material Split, Cut or Torn; Failure to Deliver; Material Split, Cut or Torn

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS LOADED INTO CARTRIDGE SEAMLESSLY. WHEN THE IOL WAS INJECTED, IT WAS TRAPPED IN A TUNNEL OBSERVING THE DAMAGED OPTICS. THE IOL WAS REMOVED WHERE SUCH DAMAGE WAS EVIDENCED. THE SURGERY WAS COMPLETED ON SAME DAY WITH UNSPECIFIED REPLACEMENT IOL. ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS NOT IMPLANTED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22459441 ↗
• MalfunctionJun 25, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED HAPTIC WAS DETACHED FROM LENS AFTER IMPLANTING. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22329656 ↗
• MalfunctionMar 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, LENS WAS CRACKED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689816 ↗
• MalfunctionMar 7, 2025Failure to Deliver; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAILURE PLACEMENT, IMPLANT STUCK TO THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21548883 ↗
• MalfunctionJan 31, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION, THE SURGEON NOTICED A BROKEN/SEVERED HAPTICS AND A 'TORN UP' LENS. SURGEON REMOVED LENS AND REPLACED IT DURING INITIAL PROCEDURE. AS PER REPORTER THERE WAS NO OTHER KNOWN CAUSE OF INCIDENCE OTHER THAN LENS FELT TIGHT DURING IMPLANTATION. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT IMPACT. THE LOT NUMBER OF THE COMPANY CARTRIDGE WAS REMOVED FROM THE FACILITY PROACTIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283066 ↗
• MalfunctionDec 13, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UNSURE IF THE REPORTED EVENT WAS A LENS ISSUE OR AN ISSUE WITH THE COMPANY CARTRIDGE. THE LENS BECAME STUCK IN THE CARTRIDGE AND WOULD NOT ADVANCE EASILY. WHEN WE WERE FINALLY WERE ABLE TO GET IT TO ADVANCE THE LENS WAS DAMAGED AND DESTROYED. IT WAS ON THE STERILE FIELD BUT WAS NOT IMPLANTED. THE PHYSICIAN REALIZED THERE WAS AN ISSUE WHEN IT TOOK MORE FORCE TO TRY TO ADVANCE IT. OBTAINED A NEW CARTRIDGE AND LENS AND HAD NO ISSUES AFTER THAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922234 ↗
• InjuryNov 28, 2024Defective Device; Defective Device

  A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DAMAGE TO A TRAILING HAPTIC OCCURRED AFTER INSERTION THROUGH A 2.4 MILLIMETER (MM) INCISION. THE INCISION WAS THEN ENLARGED TO A REMOVAL SIZE OF 2.75 MM, ALLOWING THE IOL TO BE EXPLANTED. FOLLOWING THIS, TWO BACKUP IOLS WERE ATTEMPTED FOR IMPLANTATION ONE AFTER THE OTHER DURING THE SAME PROCEDURE; HOWEVER, BOTH WERE FOUND TO BE DEFECTIVE FOR THE SAME REASON AND WERE SUBSEQUENTLY EXPLANTED. THE DEFECTIVE LENSES WERE THEN REPLACED WITH A NON-COMPANY LENS DURING THE INITIAL PROCEDURE. THE ENTIRE PROCESS WAS COMPLETED ON THE SAME DAY. THE SURGEON CONSIDERED THAT THERE WAS A FAULT IN SETTING THE IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE SURGEON CONSIDERED THAT THE IOL MIGHT NOT BE PRESSED FIRMLY AGAINST THE BOTTOM OF THE CARTRIDGE WHEN SETTING THE IOL.

  Patient problems: Eye Injury

  MAUDE report 20805403 ↗
• InjuryNov 28, 2024Defective Device; Defective Device

  A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DAMAGE TO A TRAILING HAPTIC OCCURRED AFTER INSERTION THROUGH A 2.4 MILLIMETER (MM) INCISION. THE INCISION WAS THEN ENLARGED TO A REMOVAL SIZE OF 2.75 MM, ALLOWING THE IOL TO BE EXPLANTED. FOLLOWING THIS, TWO BACKUP IOLS WERE ATTEMPTED FOR IMPLANTATION ONE AFTER THE OTHER DURING THE SAME PROCEDURE; HOWEVER, BOTH WERE FOUND TO BE DEFECTIVE FOR THE SAME REASON AND WERE SUBSEQUENTLY EXPLANTED. THE DEFECTIVE LENSES WERE THEN REPLACED WITH A NON-COMPANY LENS DURING THE INITIAL PROCEDURE. THE ENTIRE PROCESS WAS COMPLETED ON THE SAME DAY. THE SURGEON CONSIDERED THAT THERE WAS A FAULT IN SETTING THE IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE SURGEON CONSIDERED THAT THE IOL MIGHT NOT BE PRESSED FIRMLY AGAINST THE BOTTOM OF THE CARTRIDGE WHEN SETTING THE IOL.

  Patient problems: Eye Injury

  MAUDE report 20805397 ↗
• InjuryNov 28, 2024Defective Device; Defective Device

  A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DAMAGE TO A TRAILING HAPTIC OCCURRED AFTER INSERTION THROUGH A 2.4 MILLIMETER (MM) INCISION. THE INCISION WAS THEN ENLARGED TO A REMOVAL SIZE OF 2.75 MM, ALLOWING THE IOL TO BE EXPLANTED. FOLLOWING THIS, TWO BACKUP IOLS WERE ATTEMPTED FOR IMPLANTATION ONE AFTER THE OTHER DURING THE SAME PROCEDURE; HOWEVER, BOTH WERE FOUND TO BE DEFECTIVE FOR THE SAME REASON AND WERE SUBSEQUENTLY EXPLANTED. THE DEFECTIVE LENSES WERE THEN REPLACED WITH A NON-COMPANY LENS DURING THE INITIAL PROCEDURE. THE ENTIRE PROCESS WAS COMPLETED ON THE SAME DAY. THE SURGEON CONSIDERED THAT THERE WAS A FAULT IN SETTING THE IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE SURGEON CONSIDERED THAT THE IOL MIGHT NOT BE PRESSED FIRMLY AGAINST THE BOTTOM OF THE CARTRIDGE WHEN SETTING THE IOL.

  Patient problems: Eye Injury

  MAUDE report 20805396 ↗
• MalfunctionSep 13, 2024Crack; Crack

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY HAVE NOTICED THAT THE LENS WAS CRACKED AFTER IMPLANTING INTO THE PATIENT EYE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAVE BEEN RECEIVED IT STATES THAT THE LENS WAS REMOVED AND REPLACED WITH UNSPECIFIED ANOTHER LENS WITH SAME TYPE AND DIOPTER. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20210125 ↗
• MalfunctionSep 5, 2024Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH AROUND A LENS AREA WAS FOUND AFTER INSERTION. THE SCRATCH SEEMED TO EXPAND IN 5 TO 6 O'CLOCK DIRECTION. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT; THE LENS HAD REMAINED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20143558 ↗
• MalfunctionApr 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BROKE/TORE INTO 3 PIECES WHEN INSERTING INTO THE PATIENT. THE PATIENT CONTACT WAS NOTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16741824 ↗
• MalfunctionJan 19, 2023Crack; Crack

  A HEALTH CARE PROFESSIONAL REPORTED A CRACK IN THE LENS PERIPHERALLY ONCE IT WAS IMPLANTED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16204513 ↗
• MalfunctionJan 18, 2023Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT A SMALL PERIPHERAL CRACK WAS FOUND ON THE OPTIC AT THE INNER TRAILING HAPTIC JUNCTION AND ALSO A VERY SMALL CRACK AT THE SAME LOCATION AT THE LEADING OPTIC EDGE.

  Patient problems: Insufficient Information

  MAUDE report 16194190 ↗