Clareon SY60WF (UDI 00380652251563)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Clareon SY60WF is a foldable acrylic intraocular lens implanted in the eye during cataract surgery. The 46 reports mostly describe the lens being damaged before or during implantation — scratched, cracked, bent, or with a torn haptic arm — so it often had to be removed and replaced with another lens during the same operation. Three reports describe injuries, and no deaths were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00380652251563), received between Sep 16, 2022 and Sep 25, 2026 — classified as 4 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (13 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.
Reports received per month
Most reported problems
Device problems
- Scratched Material13
- Break8
- Crack8
- Defective Device4
- Adverse Event Without Identified Device or Use Problem3
- Failure to Deliver3
- Material Split, Cut or Torn3
- Material Twisted/Bent3
Patient problems
- Insufficient Information24
- No Clinical Signs, Symptoms or Conditions20
- Visual Impairment3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Corneal Edema1
- Endophthalmitis1
- Hypopyon1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the patient experienced dangerous glare and depth perception. Patient needed immediate assistance. Additional information has been received and stated, patient would be having a second opinion and had a hope to have the lens removed. Patient had suffered for a year of life due to these lenses. Patient was dissatisfied and very frustrated.
Patient problems: Visual Disturbances
MAUDE report 50894917 ↗MalfunctionJul 7, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTICS WERE DEFECTIVE, AS THE LENS COULD NOT BE LOADED CORRECTLY AND WAS NOT USED AFTER OPENING. THE INITIAL 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 25730580 ↗MalfunctionMar 30, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS TORN. THE IOL WAS REMOVED AND REPLACED BY A SIMILAR LENS ON SAME DAY. THERE WAS NO PATIENT HARM AND PATIENT'S CURRENT CONDITION WAS SATISFACTORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715811 ↗MalfunctionMar 3, 2026Material Deformation
A FACILITY REPRESENTATIVE REPORTED AS BENT LENS. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24496962 ↗MalfunctionFeb 27, 2026Material Deformation
A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE LENS WAS DAMAGED. THE LENS WAS NOT USED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24469616 ↗MalfunctionFeb 27, 2026Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON OBSERVED A CRACK ON THE IOL OPTIC AFTER THE LENS HAD BEEN IMPLANTED IN THE EYE. THE IOL WAS SUBSEQUENTLY EXPLANTED DURING THE SAME INITIAL PROCEDURE, WHICH WAS COMPLETED ON THE SAME DAY. THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468978 ↗MalfunctionFeb 4, 2026Scratched Material
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED IN DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING LENS WAS NOTICED TO BE SCRATCHED AFTER IMPLANTED. IN THE SURGEON'S OPINION, IT WAS UNKNOWN IF PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THE LENS WAS EXCHANGED DURING SAME PROCEDURE, AND THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257055 ↗MalfunctionDec 2, 2025Break; Break
A PHARMACIST REPORTED THAT THE HAPTIC TORN DURING INTRAOCULAR INSERTION. THE LENS WAS EXPLANTED AND IMPLANTED WITH A NEW UNSPECIFIED LENS OF SAME DIOPTER DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23693923 ↗InjuryJul 29, 2025Break; Break
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE TRAILING HAPTIC WAS TORN OFF AFTER IMPLANTING THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH BACKUP LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE REMAINED INSIDE THE CARTRIDGE AND THE CORNEAL EDEMA HAS SUBSIDED, BUT ASTIGMATISM IS THOUGHT TO HAVE INCREASED DUE TO SUTURING FOR WOUND ENLARGEMENT. HOWEVER, SINCE THE SUTURE THREAD IS ABSORBABLE, IT IS EXPECTED TO RESOLVE OVER TIME.
Patient problems: Corneal Edema; Visual Impairment
MAUDE report 22646268 ↗MalfunctionJun 10, 2025Failure to Deliver; Device Damaged by Another Device; Failure to Deliver; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT STUCK IN THE CARTRIDGE DURING IMPLEMENTATION AND DURING SUBSEQUENT MANIPULATION, NOTICED THAT IOL WAS DAMAGED. THE SURGERY WAS COMPLETED ON SAME DAY BY USING COMPANY SAME LENS MODEL. THERE WAS NO PATIENT CONTACT AND IMPACT. THE DAMAGE TO THE IOL WAS NOTICED AFTER THEY REALIZED THAT THE LENS WAS STUCK IN THE CARTRIDGE. THE LENS DID NOT GET IMPLANTED AND REMOVED FROM THE PATIENT¿S EYE. THE SECOND LENS WAS USED TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176614 ↗MalfunctionJun 6, 2025Device Difficult to Setup or Prepare; Failure to Deliver; Device Difficult to Setup or Prepare; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) STUCK IN CARTRIDGE. UNABLE TO LOAD SUCCESSFULLY DUE TO A FAULTY CARTRIDGE DESIGN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22157516 ↗MalfunctionMay 27, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE WHEN INJECTING, IT WAS NOT CENTERED SO WHEN PULLING FROM THE INCISION THE HAPTIC BROKE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22086950 ↗MalfunctionMay 16, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS PARTIALLY BROKE OFF WHILE INSERTING THE LENS INTO PATIENT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED VIA MEDWATCH FORM AND NON-HEALTHCARE PROFESSIONAL STATING THE PATIENT HAD A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT WAS PERFORMED. WHEN THE NEW LENS WAS PLACED, IT WAS NOTED THAT ONE OF THE HAPTICS HAD BROKEN OFF. THE SURGEON REMOVED THE BROKEN HAPTIC AND LEFT THE LENS IN PLACE BECAUSE SURGEON FELT THAT THERE WAS ENOUGH OF HAPTIC LEFT TO HOLD THE LENS IN PLACE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22037449 ↗MalfunctionApr 24, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN AND THE LENS HALF INSERTED AND PULLED BACK BEFORE FULLY IMPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21900672 ↗MalfunctionApr 2, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED DURING LENS INSERTION, IT WAS NOTED THAT THE LEAD HAPTIC WAS KINKED SO THE LENS WAS PULLED BACK OUT AND A NEW LENS OPENED AND SUCCESSFULLY INSERTED. NO PATIENT INJURY OR ERROR AND MINIMAL DELAY IN THE PROCEDURE. THE LENS WAS NOT FULLY INSERTED. IN THE SURGEON OPINION POSSIBLE LOADING ERROR BY THE TECHNICIAN WAS THE CAUSE OF THE EVENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21754359 ↗MalfunctionMar 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT AT THE TIME OF INTRAOCULAR LENS (IOL) INSPECTION IN CARTRIDGE, THERE WAS A CRACK IN THE IOL OPTIC. THE DOCTOR BELIEVED THAT THE CRACK WAS CREATED FROM DEFECTIVE CARTRIDGE. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21689942 ↗MalfunctionMar 18, 2025Dent in Material; Dent in Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS CHIPPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21633784 ↗MalfunctionMar 14, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE AT THE TIME OF IOL PLACEMENT IN THE CARTRIDGE, THE SURGEON NOTICED THAT THE IOL HAPTIC WAS PARTIALLY DETACHED, WITH A FAILURE OR CRACK. THEREFORE, SURGEON WAS DECIDED NOT TO IMPLANT IT AND USED ANOTHER NEW IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604506 ↗MalfunctionMar 13, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED WITH DESCRIPTION DEFECTIVE NOT IMPLANTED. ADDITIONAL INFORMATION RECEIVED THAT THE LENS WAS BROKEN DURING LOADING OF THE LENS. THE SURGERY COMPLETED WITH REPLACEMENT LENS. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LEG BROKE DURING LOADING PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21593744 ↗MalfunctionFeb 4, 2025Break; Defective Component; Break; Defective Component
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT OUTER END SURFACE WAS MISSING FROM THE LENS HAPTIC WHEN THE LENS HAD JUST BEEN FOLDED INTO THE CARTRIDGE. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS NOT SIGNIFICANTLY DELAYED AND WAS THEN COMPLETED WITH A UNSPECIFIED REPLACEMENT LENS OF THE SAME POWER. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21302940 ↗MalfunctionDec 3, 2024Material Split, Cut or Torn; Failure to Eject; Material Split, Cut or Torn; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION PROCEDURE THE DID NOT ADVANCE AS EXPECTED. THE LENS DID NOT ADVANCE COMPLETELY FROM THE CARTRIDGE AND BROKE IN PIECES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20829322 ↗MalfunctionJun 20, 2024Defective Device; Defective Device
ANOTHER HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION DAMAGED IMPLANT. NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19573624 ↗MalfunctionMay 10, 2024Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 19287545 ↗MalfunctionMar 26, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DUE TO AN UNSPECIFIED ISSUE THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS SCRATCH ON LENS. THERE WAS NO PATIENT HARM. THE ORIGINALLY SCHEDULED PROCEDURE COMPLETED THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18976984 ↗MalfunctionMar 13, 2024Scratched Material; Scratched Material
ADDITIONAL INFORMATION WAS REQUESTED, AND RECEIVED PREVIOUSLY IT WAS STATED PATIENT WAS LEFT APHAKIC. NEW INFORMATION STATES PATIENT WAS NOT LEFT APHAKIC. LENS WAS REPLACED WITH ANOTHER LENS WITH COMPANY SAME MODEL AND DIOPTER LENS IMPLANTED ON SAME DAY.
Patient problems: Insufficient Information
MAUDE report 18894091 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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