Clareon SY60WF (UDI 00380652251556)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00380652251556), received between Feb 8, 2022 and Sep 18, 2026 — classified as 5 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (11 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  A non-healthcare professional reported that during a cataract surgery with intraocular lens (IOL) implantation procedure, the haptic detached from the optic at the time of insertion. Consequently, the lens was removed and replaced with same model and diopter of company lens.Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50814626 ↗
• MalfunctionAug 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50500875 ↗
• MalfunctionAug 6, 2026Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 50155411 ↗
• MalfunctionJul 14, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 25814116 ↗
• MalfunctionJun 5, 2026Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, END PART OF HAPTIC WAS BROKEN WHILE THE IOL WAS BEING INSERTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25407634 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  A REGISTERED NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT CHANGED HER MIND ¿ SHE WANTED TO SEE FAR RATHER THAN NEAR. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH AN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24619543 ↗
• MalfunctionMar 16, 2026Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY OBSERVED SOMETHING ON THE OPTIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24603241 ↗
• MalfunctionJan 2, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC GOT STUCK IN THE CARTRIDGE AND BROKE OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23943455 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED MAJOR VISION PROBLEMS AS VISION WAS NOT AS EXPECTED. THE EYE REMAINED TENDER AFTER MONTHS, AND PATIENT CAN NO LONGER DRIVE AT NIGHT BECAUSE OF BLINDING HALOS FROM HEADLIGHTS. THE SURGEON HAD NO SOLUTION. THE PATIENT HAD SCHEDULED FOR 2ND OPINION WITH ANOTHER PHYSICIAN. THE PATIENT ALSO WANT TO KNOW IF THERE WAS LENS DEFECT. ADDITIONAL INFORMATION HAD BEEN RECEIVED AND STATED ON (B)(6) 2025 THE PATIENT WAS ONE DAY POST-OP AFTER CATARACT SURGERY. THE EYE LOOKED GREAT AND THE WOUND WAS WELL CLOSED. THE LENS WAS CENTERED, CLEAR AND THERE WAS VERY LITTLE INFLAMMATION, WITHIN NORMAL LIMITS FOR DAY ONE. THE SURGEON COUNSELED THE PATIENT ABOUT CORRECT DROP USAGE AND ASKED THE PATIENT TO CALL IMMEDIATELY FOR PAIN, REDNESS, LOSS OF VISION OR ANY OTHER SIGNS OF PROBLEMS. ON THE SAME DAY THE PATIENT COMPLAINS OF LOTS OF PAIN IN RIGHT EYE AFTER SURGERY. THE PATIENT CALLED AND WAS TOLD TO TAKE OFF PATCH AND USE COMBO DROP AND REFRESH PRESERVATIVE-FREE TEARS IN BETWEEN, TOOK ACETAMINOPHEN. PAIN MUCH BETTER. THE PATIENT DID NOT USE ORAL DROP AT HOME ON TH

  Patient problems: Blurred Vision; Eye Irritation; Eye Pain; Keratitis; Visual Disturbances

  MAUDE report 23647009 ↗
• MalfunctionSep 16, 2025Material Deformation; Material Deformation

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23061970 ↗
• InjurySep 15, 2025Optical Decentration; Optical Decentration

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS DECENTERED AFTER IMPLANTATION AND THE DOCTOR SUSPECTED THAT THE CAPSULAR BAG EXTENDED AFTER THE DELIVERY OF LENS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER SULCUS LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23051088 ↗
• MalfunctionSep 12, 2025Break; Break

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS PLACED IN THE PATIENT EYE, THE HAPTIC WAS NOTED TO BE BROKEN. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23036368 ↗
• MalfunctionSep 10, 2025Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE A SCRATCH WAS FOUND AT THE EDGE OF LENS AFTER DELIVERY INTO THE EYE. THE LENS WAS EXPLANTED DURING THE INITIAL PROCEDURE AND REPLACED WITH BACKUP LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016588 ↗
• MalfunctionSep 9, 2025Material Deformation; Material Deformation

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005536 ↗
• MalfunctionSep 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS OBSERVED THE FRACTURED IOL IN THE PATIENT¿S LEFT EYE. THE SURGERY WAS COMPLETED THE SAME DAY, THE FRACTURED IOL WAS REMOVED, AND A REPLACEMENT IOL WAS INSERTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932210 ↗
• MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTH PROFESSIONAL REPORTED THAT DURING THE DEPLOYMENT OF THE IMPLANT IN THE CARTRIDGE, THE HAPTICS DID NOT BEND. THE DEVICE CAME INTO CONTACT WITH THE PATIENT'S LEFT EYE AND THE INCIDENT DOES NOT REQUIRE LENS REMOVAL. HENCE THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22802169 ↗
• MalfunctionAug 7, 2025Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS INJECTED INTO THE EYE, A SCRATCH WAS OBSERVED ON ITS SURFACE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE, AND A SUBSEQUENT SECOND LENS WAS IMPLANTED. THE SECOND LENS ALSO SHOWED A SCRATCH IN THE SAME LOCATION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE WOUND DID NOT NEED TO BE ENLARGED, AND NO ADDITIONAL STITCHES WERE REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BOTH LENSES HAD A SCRATCH IN THE SAME PERIPHERAL AREA AT THE BOTTOM OF THE LENS. THE SECOND IOL REMAINED IN THE EYE. A COMPANY CARTRIDGE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 22739594 ↗
• MalfunctionAug 7, 2025Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS INJECTED INTO THE EYE, A SCRATCH WAS OBSERVED ON ITS SURFACE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE, AND A SUBSEQUENT SECOND LENS WAS IMPLANTED. THE SECOND LENS ALSO SHOWED A SCRATCH IN THE SAME LOCATION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE WOUND DID NOT NEED TO BE ENLARGED, AND NO ADDITIONAL STITCHES WERE REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BOTH LENSES HAD A SCRATCH IN THE SAME PERIPHERAL AREA AT THE BOTTOM OF THE LENS. THE SECOND IOL REMAINED IN THE EYE. A COMPANY CARTRIDGE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 22739589 ↗
• MalfunctionAug 6, 2025Failure to Deliver; Failure to Deliver

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS STUCK IN CARTRIDGE AND WOULD NOT ADVANCE. THE SURGERY WAS COMPLETED THE REPLACEMENT LENS. THERE WAS PATIENT CONTACT.

  Patient problems: Insufficient Information

  MAUDE report 22725258 ↗
• MalfunctionJul 23, 2025Product Quality Problem; Product Quality Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PRE-MOUNTED LENS HAD TWO SMALL OVAL SHAPED IMPERFECTIONS ON THE ANTERIOR SURFACE OF THE OPTIC ZONE. THEY ARE LOCATED OUTSIDE THE VISUAL AXIS (APPROXIMATELY 3.5 MM OR 4 MM FROM THE OPTICAL CENTER). THIS WAS NOT A FRACTURE, BUT RATHER AN IMPERFECTION ON THE ANTERIOR SURFACE, RESEMBLED AS A FLAT BUBBLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22573732 ↗
• MalfunctionJun 11, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT THE LENS WAS DEFORMED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT DURING THE MOVEMENT OF THE IOL THROUGH THE CARTRIDGE EVEN BEFORE ENTERING THE NARROW PART OF THE CARTRIDGE POSTERIOR HAPTIC WAS SEPARATED WHEN ADVANCED THE LENS. THERE WAS NO STICKING OF THE HAPTICS TO THE PLUNGER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187328 ↗
• MalfunctionApr 23, 2025Product Quality Problem; Failure to Deliver; Material Split, Cut or Torn; Product Quality Problem; Failure to Deliver; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT DURING A PHACO SURGERY, THEY NOTICED THAT THE IOL BROKE AT THE OPTIC-HAPTIC JUNCTION (TRAILING) AS IT GOT STUCK IN THE INJECTOR PLUNGER. NO PATIENT IMPACT WAS REPORTED AND AN ANOTHER IOL WAS IMPLANTED TO COMPLETE THE SURGERY. EVENT WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT, SURGEON FELT IOL HAD SOME ISSUE AND ALSO THE INJECTOR(NON COMPANY) WAS NOT SMOOTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893041 ↗
• MalfunctionApr 2, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SOME RESISTANCE AT THE TIME OF IMPLANTATION. THE LENS WAS DISCARDED AND USED SAME CARTRIDGE TO IMPLANT THE SECOND IOL THE LENS WAS DAMAGED BY LOADING ERROR. IT IS UNKNOWN IF THE CARTRIDGE CAUSED THE DAMAGE TO THE LENS OR LOADING ERROR. IN SURGEON OPINION THE INJECTOR CAUSED THE DAMAGE. THE LENS WAS LEFT IN THE PATIENT EYE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755422 ↗
• MalfunctionApr 2, 2025Device Difficult to Setup or Prepare; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SOME RESISTANCE AT THE TIME OF IMPLANTATION. THE LENS WAS DISCARDED AND USED SAME CARTRIDGE TO IMPLANT THE SECOND IOL THE LENS WAS DAMAGED BY LOADING ERROR. IT IS UNKNOWN IF THE CARTRIDGE CAUSED THE DAMAGE TO THE LENS OR LOADING ERROR. IN SURGEON OPINION THE INJECTOR CAUSED THE DAMAGE. THE LENS WAS LEFT IN THE PATIENT EYE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753798 ↗
• MalfunctionFeb 10, 2025Product Quality Problem; Product Quality Problem

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

  Patient problems: Insufficient Information

  MAUDE report 21342880 ↗