Clareon SY60WF (UDI 00380652251419)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380652251419), received between Jul 12, 2022 and Sep 24, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  A non-health care professional reported that during the intraocular lens (IOL) implantation surgery, the haptic was broken once the lens was implanted in the eye. Hence the surgeon removed the lens and replaced it with another lens during the same procedure. According to the surgeon, the defective lens caused or contributed to the event. There was no patient harm. Additional information was received stating that, the trailing haptic was broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884977 ↗
• MalfunctionAug 12, 2026Failure to Deliver

  Patient problems: Insufficient Information

  MAUDE report 50218958 ↗
• MalfunctionAug 3, 2026Failure to Deliver

  Patient problems: Insufficient Information

  MAUDE report 50116876 ↗
• MalfunctionFeb 13, 2026Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENSES FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS IS 1 OF 4.

  Patient problems: Insufficient Information

  MAUDE report 24332988 ↗
• MalfunctionJan 12, 2026Failure to Deliver

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS MISFIRED AND IT WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, DOCTOR JUST STARTED LOADING THE LENS HIMSELF AND IF HE FEELS THAT HE DID SOMETHING WRONG AND THERE WAS THE POSSIBILITY OF THE LENS BEING SCRATCHED HE REQUESTS ANOTHER LENS.

  Patient problems: Insufficient Information

  MAUDE report 24034414 ↗
• MalfunctionJan 8, 2026Failure to Deliver

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS MISFIRED AND IT WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, DOCTOR JUST STARTED LOADING THE LENS HIMSELF AND IF HE FEELS THAT HE DID SOMETHING WRONG AND THERE WAS THE POSSIBILITY OF THE LENS BEING SCRATCHED HE REQUESTS ANOTHER LENS.

  Patient problems: Insufficient Information

  MAUDE report 24003887 ↗
• MalfunctionJul 3, 2025Break; Break

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY NOTICED THAT UPON INSERTING THE LENS, ONE HAPTIC WAS NOTED TO BE ALMOST SEVERED. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER UNSPECIFIED LENS BY USING A NEW CARTRIDGE DURING INITIAL PROCEDURE. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 22393977 ↗
• MalfunctionMar 12, 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 21582235 ↗
• MalfunctionJan 2, 2025Failure to Advance; Failure to Advance

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS STUCK IN DELIVERY SYSTEM OR WOULD NOT ADVANCE ON INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 21056340 ↗
• MalfunctionFeb 13, 2024Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) CRACKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 6 OF 6.

  Patient problems: Insufficient Information

  MAUDE report 18694447 ↗
• InjuryFeb 2, 2024Adverse 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, PROBLEMS WITH HALOS AND STARBURST. THESE PROBLEMS HAVE MADE IT VERY DIFFICULT TO NIGHT DRIVE. THE PATIENT HAS SEEN PHYSICIAN NUMEROUS TIMES OVER THE YEAR. THE PHYSICIAN HAS PERFORMED A 'YAG' PROCEDURE TO ELIMINATE THE 'SECONDARY CATARACT' IN HOPES THAT IT WOULD RESOLVE THE PROBLEM. HOWEVER, THE SYMPTOMS WERE CONTINUING, AND CONSUMER HAVE INFORMED TO PHYSICIAN THAT IT SEEMS TO ME THAT THE LENS IS MOVING IN EYE AS CONSUMER CAN SEE THE MOVEMENT (MY PULSE FOR EXAMPLE). THIS IS MOST NOTICEABLE IF I TILT MY HEAD TO THE SIDE. THE PHYSICIAN DISMISSED MY CLAIM AND STATED I WAS SEEING A SHADOW BUT NOT THE CASE. THE PATIENT HAS ASKED IF THE LENS IS DESIGNED WITH CONCENTRIC CIRCLES ON THE SURFACE AS I SEE THESE CIRCLES IN THE GLARE FROM OVERHEAD LIGHT. THE PHYSICIAN INFORMED ME THAT IT DOES NOT. THE CONSUMER UNABLE TO WORK IN AN OFFICE WITH OVERHEAD LIGHTS DUE TO GLARE/HALOS AND UNABLE TO COMFORTABLY WATCH TV (TELEVISION) IN HOME WITH OVERHEAD LIGHTS ON. THE PATIENTS CONCERN THAT I WAS TO HAVE MY RIGHT EYE CATARACT LENS DONE AS WELL, WHICH WILL HELP WITH THE VISION DIFFERENCES BETWEEN THE TWO. WHEN I BROUGHT THIS U

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diplopia/Double Vision; Halo; Visual Disturbances

  MAUDE report 18629817 ↗
• MalfunctionNov 27, 2023Scratched Material; Scratched Material

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT NO MALFUNCTION WITH THE LENS. WITH AVAILABLE INFORMATION, THE FILE WAS REVIEWED AND REASSESSED AND IT HAS BEEN DETERMINED THAT THERE WAS NO REPORTED DEFECT OR FAULT WITH A COMPANY PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 18208110 ↗
• MalfunctionSep 15, 2023Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17756558 ↗
• MalfunctionApr 9, 2023Defective Device; Defective Device

  A PURCHASING COORDINATOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL DEFECT WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE IOL HAD TO BE REMOVED DUE TO DEFECT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705230 ↗
• MalfunctionJan 20, 2023Crack; Crack

  A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PERIPHERAL SMALL CRACK BY OPTIC/HAPTIC JUNCTURE NOTED. THE LENS REMAINS IN PATIENT EYE.

  Patient problems: Insufficient Information

  MAUDE report 16213154 ↗
• MalfunctionNov 4, 2022Crack; Crack

  A REPORT WAS RECEIVED FROM THE FDA-MEDWATCH AND REPORTED THAT, INTRAOCULAR LENS (IOL) OPTIC EDGE AT HAPTIC JUNCTION, VERY SMALL CRACK AT OPTIC EDGE.

  Patient problems: Insufficient Information

  MAUDE report 15735289 ↗
• MalfunctionJul 12, 2022Device Damaged by Another Device; Device Damaged by Another Device

  A NURSE WAS REPORTED THAT, DURING AN IMPLANTATION OF INTRAOCULAR LENS (IOL), A SCRATCH WAS FOUND AFTER IMPLANT AND IT WAS OBSERVED WHEN SEEN UNDER MICROSCOPE. THE LENS WAS REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE SURGERY WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 14985036 ↗