Clareon SY60WF (UDI 00380652251617)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
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652251617), received between Aug 17, 2022 and Sep 25, 2026 — classified as 2 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (3 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 Material3
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
- Defective Device1
- Device Dislodged or Dislocated1
- Material Split, Cut or Torn1
- Suction Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information5
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Scratched Material
A nurse reported that during an intraocular lens (IOL) implantation procedure, the IOL was scratched and there was no further impact to the patient. Additional information was requested but was not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894959 ↗InjuryJul 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT LENS WAS EXPLANTED WITH THE REASON WRONG POWER. THE LENS WAS EXCHANGED WITH COMPANY LENS OF DIFFERENT MODEL. ADDITIONAL INFORMATION RECEIVED THAT THE WOUND WAS ENLARGED AND SUTURE WAS USED. THE PATIENT HAD ANTERIOR VITRECTOMY.
Patient problems: Insufficient Information
MAUDE report 22403655 ↗MalfunctionApr 3, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21760477 ↗MalfunctionMar 26, 2025Break; Break
A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON IMPLANTING THE LENS INTO THE EYE, THE TRAILING HAPTIC WAS NOTED TO BE COMPLETELY SEVERED. THE REST OF THE HAPTIC WAS LATER FOUND ON THE LENS INSERTING FORCEPS. THE LENS WAS EXPLANTED AND REPLACED WITH NEW UNSPECIFIED LENS DURING INITIAL PROCEDURE. THE PATIENT HAD DEMENTIA, NARROW ANGLES WITH SHALLOW AC (ANTERIOR CHAMBER), HAZY CORNEA, AND WAS MOVING SIGNIFICANTLY DURING SURGERY. THE PATIENT COULD NOT STAY STILL FOR EXPLANTATION SO AFTER MUCH DIFFICULTY ENDED UP HAVING TO CONVERT TO GENERAL ANESTHESIA IN ORDER TO COMPLETE THE CASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21695120 ↗MalfunctionJan 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT LENS OPTIC BROKEN/CRACKED/SPLIT/TORN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21054013 ↗MalfunctionSep 13, 2024Defective Component; Defective Component
A NURSE REPORTED THAT DURING SURGERY, THEY HAD AN UNSPECIFIED ISSUE WITH THE LENS. SO, IT WAS NOT USED AND SURGEON OPTED TO USE ANOTHER LENS. THERE WAS PATIENT CONTACT NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20211977 ↗MalfunctionJul 11, 2024Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING SURGERY, THREE LENSES WERE SCRATCHED. IT WAS NOTICED DURING IMPLANTATION OF THE LENS AND ONE OF THE LENS HAD TO BE EXPLANTED. THERE WAS PATIENT CONTACT HOWEVER NO PATIENT HARM. SAMPLE HAS BEEN DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO THE LEFT EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19725668 ↗MalfunctionJul 11, 2024Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING SURGERY, THREE LENSES WERE SCRATCHED. IT WAS NOTICED DURING IMPLANTATION OF THE LENS AND ONE OF THE LENSES HAD TO BE EXPLANTED. THERE WAS PATIENT CONTACT HOWEVER NO PATIENT HARM. SAMPLE HAS BEEN DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS EXPLANTED AND REPLACED WITH NEW LENS ON THE SAME DAY. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO THE RIGHT EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19725363 ↗InjuryJul 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD MAJOR POST OP ROTATION OF LENS. THE PATIENT DID GET ROTATION 2 TIMES. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS ASSOCIATED WITH MULTIPLE PATIENT COMPLAINTS. THIS FILE IS FOR PATIENT 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19680763 ↗MalfunctionFeb 17, 2024Suction Failure; Suction Failure
A PHYSICIAN REPORTED THAT THE ASPIRATION DID NOT RISE DURING PHACO MODE OF CATARACT SURGERY (WITH INTRAOCULAR LENS (IOL) IMPLANT). THE SURGERY WAS SUCCESSFULLY COMPLETED WITH THE REPLACEMENT OF THE FLUIDICS MANAGEMENT SYSTEM (FMS) PAK. THERE WAS NO PATIENT HARM. THIS REPORT PERTAINS TO PHACOEMULSIFICATION TIP INVOLVED IN THIS REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED FOR THIS REPORT THE MODE OF THE SURGERY WAS PHACO MODE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728163 ↗MalfunctionAug 17, 2022Defective Device; Defective Device
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL FOUND TO HAVE DEFECT. THERE WAS A PATIENT CONTACT NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 15244571 ↗
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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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