Clareon SY60WF (UDI 00380652251457)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 an implantable lens used during cataract surgery. Most of the 36 reports describe the lens being scratched, cracked, split, or broken while being handled or implanted, and a few mention blurred vision or a scratch on the eye's surface. There are 8 injuries and no deaths. No recalls name 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
- 38
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00380652251457), received between Sep 15, 2022 and Sep 25, 2026 — classified as 8 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (8 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 Material8
- Break6
- Material Split, Cut or Torn6
- Adverse Event Without Identified Device or Use Problem5
- Crack3
- Failure to Deliver3
- Defective Device2
- Device Dislodged or Dislocated2
Patient problems
- Insufficient Information25
- No Clinical Signs, Symptoms or Conditions9
- Visual Impairment3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Capsular Bag Tear1
- Corneal Perforation1
- Eye Infections1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Break
A physician reported that during loading for a cataract surgery involving intraocular lens (IOL) implantation, it was observed that the haptic was broken. The surgery was completed on the same day. There was no patient contact with the affected device.According to additional information received, the trailing haptic was broken. The surgery was completed on the same day using another IOL. The patient's current condition is good.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897324 ↗MalfunctionSep 15, 2026Failure to Deliver
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure. lens got stuck in cartridge.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50774803 ↗MalfunctionAug 25, 2026Material Twisted/Bent
A nurse reported that during an intraocular lens (IOL) implantation procedure, the lens container was opened, and while the lens was being removed with forceps, one haptic remained in the container. The procedure was completed on the same day using another unspecified lens. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50431540 ↗InjuryApr 14, 2026Break; Device Dislodged or Dislocated
A GOVERNMENT AGENCY REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ON DAY ONE, THE PATIENT WITH AN EXISTING CONDITION OF SENILE CATARACT WAS IMPLANTED WITH AN INTRAOCULAR LENS AFTER THE CATARACT WAS EXTRACTED USING PHACOEMULSIFICATION DURING THE OPERATION. THE PHYSICIAN CHECKED THAT THE EXTERNAL PACKAGE OF THE INTRAOCULAR LENS AND THE PRELOADED HANDLE WERE INTACT. AFTER OPENING, SODIUM HYALURONATE GEL WAS INJECTED INTO THE INTRAOCULAR LENS. THE INTRAOCULAR LENS WAS IMPLANTED INTO THE CAPSULE THROUGH THE MAIN INCISION IN THE LEFT EYE OF THE PATIENT. BECAUSE THE INTRAOCULAR LENS LOOP STABILIZED THE INTRAOCULAR LENS IN THE CAPSULE, WHILE CAREFULLY ADJUSTING THE POSITION OF THE INTRAOCULAR LENS, IT WAS FOUND THAT ONE SIDE OF THE INTRAOCULAR LENS LOOP WAS BROKEN AT THE IMPLANT HEAD. THE INTRAOCULAR LENS IMPLANTATION AND FIXATION WERE CHECKED. THE INJECTOR AND THE BROKEN LENS LOOP WERE SLOWLY REMOVED. SODIUM HYALURONATE GEL WAS INJECTED INTO THE ANTERIOR CHAMBER, THE MAIN INCISION AND AUXILIARY INCISION WERE SEALED WITH WATER, AND TOBRAMYCIN AND DEXAMETHASONE EYE OINTMENT WERE APPLIED TO THE CONJUNCTIVAL SAC FOR SINGLE-EYE COVERAGE. THE SURGERY WA
Patient problems: Visual Impairment
MAUDE report 24871949 ↗MalfunctionMar 25, 2026Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, TORN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24684515 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING CATARACT SURGERY INVOLVING INTRAOCULAR LENS (IOL) IMPLANTATION IN HIS LEFT EYE, HIS CORNEA WAS SCRATCHED AND HE DEVELOPED A SEVERE STAPH INFECTION WHICH ULTIMATELY RESULTED IN THE LOSS OF VISION IN THAT EYE.
Patient problems: Corneal Perforation; Eye Infections; Loss of Vision
MAUDE report 24626087 ↗MalfunctionMar 17, 2026Material Split, Cut or Torn
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 24617111 ↗MalfunctionFeb 20, 2026Scratched Material
ACCORDING TO ADDITIONAL INFORMATION RECEIVED STATED THAT THE CURRENT PATIENT CONDITION WAS DISCHARGED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24401463 ↗MalfunctionFeb 9, 2026Product Quality Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DEFECTIVE. 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 3 OF 4.
Patient problems: Insufficient Information
MAUDE report 24291570 ↗MalfunctionJan 9, 2026Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHEN PLACING IOL IN THE CAPSULAR BAG, A SCRATCH WAS SEEN THAT REACHES THE CENTER OF THE INCISION. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019801 ↗MalfunctionNov 4, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE TRYING TO IMPLANT IT WAS NOTICED THAT THE LENS HAD A BROKEN HAPTIC UNSURE IF IT CAME BROKEN OR BROKE WHILE LOADING. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE TRAILING HAPTIC BROKE. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND PROCEDURE COMPLETED WITH SAME MODEL AND DIOPTER COMPANY LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23463865 ↗MalfunctionSep 19, 2025Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DAMAGED WHEN IT WAS PUT IN THE CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23094398 ↗MalfunctionSep 10, 2025Product Quality Problem; Device Damaged Prior to Use; Product Quality Problem; Device Damaged Prior to Use
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BRITTLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23016327 ↗MalfunctionAug 6, 2025Failure to Deliver; Material Split, Cut or Torn; Failure to Deliver; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS NOT CRACKED AFTER INSERTING INTO THE INJECTION BUT WAS CRACKED AFTER INSERTING INTO THE EYE. THE REPORTER CONFIRMED THAT THE DEVICE HAD MADE CONTACT WITH THE PATIENT DURING THE ATTEMPT. THERE WAS NO IMPACT TO THE PATIENT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22726155 ↗MalfunctionJul 29, 2025Failure to Deliver; Failure to Deliver
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PROCEDURE COMPLETED SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22647118 ↗MalfunctionJul 25, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A SCRATCH IN IT AFTER IMPLANTING THE LENS. THE LENS WAS EXPLANTED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22610144 ↗MalfunctionJun 26, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22336181 ↗MalfunctionJun 5, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE BEFORE INJECTION THE SURGEON NOTICED A MARK ON IMPLANT. THE PROCEDURE WAS COMPLETED WITH COMPANY BACK UP LENS. NO CLINICAL CONSEQUENCES OBSERVED FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22150409 ↗MalfunctionJun 3, 2025Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn
A NURSE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS OPTIC AND HAPTIC WERE FOUND DAMAGED WHEN IMPLANTING. IT WAS MOST LIKELY DAMAGED TO BEGIN WITH. THE LENS WAS IMPLANTED, THEN EXPLANTED, AND THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22134163 ↗MalfunctionMay 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS CRACKED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH COMPANY SAME LENS AND MODEL. IN THE SURGEONS OPINION PRODUCT CONTRIBUTED TO EVENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105777 ↗MalfunctionMay 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTICED A CRACK IN THE LENS AFTER HE HAD INSERTED IT INTO THE PATIENT EYE. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22060305 ↗MalfunctionMay 7, 2025Inaccurate Delivery; Inaccurate Delivery
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS STUCK IN THE INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21976081 ↗MalfunctionFeb 7, 2025Inaccurate Delivery; Inaccurate Delivery
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FAILURE PLACEMENT WAS NOTICED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21331775 ↗InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED WITH UNSPECIFIED PATIENT AND CLINICAL REASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 21293850 ↗MalfunctionJan 9, 2025Scratched Material; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO IMPACT TO THE PATIENT. THE SURGEON WAS UNSURE IF THE LENS WAS SCRATCHED DURING LOADING AND INSERTION OR PRIOR.
Patient problems: Insufficient Information
MAUDE report 21113251 ↗
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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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