Clareon SY60WF (UDI 00380652251549)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 lens implanted in the eye during cataract surgery. Most of the 63 reports describe the lens or its attached haptics being damaged while still in the package or during handling in the operating room — torn, cracked, scratched, bent, or breaking apart, and sometimes failing to come out of its holder, with many surgeries completed using a replacement lens. 5 reports mention 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
- 63
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00380652251549), received between Mar 15, 2022 and Jul 27, 2026 — classified as 5 injuries, 58 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (15 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
- Material Split, Cut or Torn15
- Scratched Material12
- Break11
- Failure to Eject5
- Material Twisted/Bent5
- Adverse Event Without Identified Device or Use Problem3
- Crack3
- Defective Device3
Patient problems
- Insufficient Information34
- No Clinical Signs, Symptoms or Conditions28
- Blurred Vision1
- Eye Injury1
- Inflammation1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50017319 ↗MalfunctionJun 10, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS NOT FOLDED PROPERLY. THERE WAS NO PATIENT CONTACT AND HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456695 ↗MalfunctionMay 21, 2026Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS IMPLANTATION SURGERY IT WAS OBSERVED A CRACK LINE ON THE OPTIC VIA MICROSCOPE. THE SURGEON PLANNED TO EXPLANT THE LENS BUT THE DATE IS NOT CONFIRMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25242902 ↗MalfunctionMay 11, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOTED TO BE DAMAGED PRIOR TO IMPLANTATION AND WAS NOT PLACED IN THE PATIENT'S EYE. THE DAMAGE WAS IDENTIFIED BEFORE INSERTION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING A REPLACEMENT LENS OF THE SAME MODEL AND SAME DIOPTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145358 ↗MalfunctionMay 11, 2026Material Twisted/Bent
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS BENT AND IT WAS ALMOST TOTALLY OFF THE LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ISSUE OCCURRED DURING LOADING AND THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137886 ↗MalfunctionMay 7, 2026Scratched Material
A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A SCRATCH. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 25110029 ↗MalfunctionApr 24, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24976427 ↗MalfunctionMar 17, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF TORN OR BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24617438 ↗MalfunctionMar 17, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF TORN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24617107 ↗MalfunctionMar 16, 2026Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THREE CRACKS WERE OBSERVED IN THE OPTICAL PART. THERE WAS PATIENT CONTACT. THE SURGERY WAS COMPLETED BY REMOVING THE IOL AND REPLACING IT WITH A SAME MODEL AND DIOPTER COMPANY LENS IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. 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 24603449 ↗MalfunctionMar 13, 2026Material Twisted/Bent
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A KINK IN THE HAPTIC WHILE LOADING, SO THE LENS WAS NOT INSERTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24596645 ↗MalfunctionMar 10, 2026Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT IMPLANTED AS IT WAS BROKEN NOT WORKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24559640 ↗MalfunctionFeb 9, 2026Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED ON THE OPTICS. THE SURGEON SUSPECTS IF THE IOL SCRATCH WAS CAUSED BY THE CARTRIDGE, WHICH MIGHT HAVE HAD A BURR OR SIMILAR DEFECT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY USING THE SAME BACKUP LENS.
Patient problems: Insufficient Information
MAUDE report 24292333 ↗MalfunctionFeb 2, 2026Break
A REPORT WAS RECEIVED FROM THE REGULATORY AGENCY THAT THE PATIENT DEVELOPED PROGRESSIVE BLURRED VISION IN THE RIGHT EYE WITHOUT OBVIOUS CAUSE ONE YEAR AGO, AND HAD NO SYMPTOMS SUCH AS PAIN, TEARS, OR FOREIGN BODY SENSATION. THE VISION GRADUALLY DECLINED, AND THE SYMPTOMS WORSENED TWO MONTHS AGO. ON (B)(6) 2026, THE PATIENT WAS DIAGNOSED WITH CORTICAL SENILE CATARACT (RIGHT) AND ADMITTED TO THE HOSPITAL FOR TREATMENT. ON THE SAME DAY, CATARACT SURGERY (WITH IOL IMPLANT) AND CATARACT PHACOEMULSIFICATION WERE PERFORMED. THAT THE HAPTIC BROKE WAS FOUND DURING IMPLANTATION AND A NEW IOL WAS IMMEDIATELY REPLACED. EXTEND PATIENT IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 24234942 ↗MalfunctionJan 14, 2026Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS BROKE. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067296 ↗MalfunctionJan 9, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ANTERIOR CHAMBER AND CAPSULAR BAG WERE FILLED WITH VISCOELASTIC AND A 23.0 DIOPTER LENS WAS INSERTED INTO THE LENS. UPON INSERTION, THE TRAILING HAPTIC WAS NOTED TO BE SHEARED OFF FROM THE OPTIC, THEREFORE THE DECISION WAS MADE TO EXPLANT THE LENS. ADDITIONAL VISCOELASTIC WAS PLACED INTO THE CAPSULAR BAG AND IN THE ANTERIOR CHAMBER. THE LENS WAS REMOVED FROM THE EYE USING THE "TWIST AND OUT" TECHNIQUE USING NONCOMPANY FORCEPS AND NONCOMPANY SPATULA TO PROTECT THE ENDOTHELIUM. A NEW SAME COMPANY SAME DIOPTER LENS WAS INSERTED INTO THE POSTERIOR CHAMBER CAPSULAR BAG AND ROTATED INTO POSITION USING THE NONCOMPANY HOOK.
Patient problems: Insufficient Information
MAUDE report 24019493 ↗InjuryOct 27, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED AND STATED THAT, TRAILING HAPTIC NOTED TO BE BROKEN AFTER LENS WAS IMPLANTED. THE INCISION WAS EXTENDED, AND SAME STYLE AND DIOPTER LENS WAS IMPLANTED.
Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 23399429 ↗MalfunctionAug 29, 2025Break; Scratched Material; Break; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED BY STATING, HAPTIC RIPPED OFF OF LENS PRIOR TO LOADING. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22921257 ↗MalfunctionAug 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER PLACING LENS IN TO THE EYE IT WAS NOTICED THAT LENS WAS TORN AND IT WAS CUT OUT FROM THE EYE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809166 ↗MalfunctionJul 24, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC OF THE LENS WAS TRAPPED IN THE INJECTOR WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586368 ↗MalfunctionJun 26, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED LEADING HAPTIC WAS COMPLETELY BROKEN OFF AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE AND REPLACED WITH NEW ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22337171 ↗MalfunctionJun 19, 2025Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON HAD TROUBLE INSERTING THE LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT WHEN PLACING THE LENS IN CAPSULE SURGEON HAD A LITTLE RESISTANCE, BUT INSERTED. THE BACK HAPTIC DIDN'T FULLY INSERT. THE SURGERY COMPLETED SAME DAY WITH SAME MODEL AND DIOPTER COMPANY LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293076 ↗MalfunctionJun 10, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOLDED WELL, INSERTED WELL; HOWEVER, THEY NOTED 1 MM TIP PIECE BROKE OFF LAYING ON THE LENS FIELD. THE SURGEON REMOVED IT EASILY AND LENS WAS USABLE AS IT WAS JUST A PIECE NOTED. THE HAPTIC WAS NOT BROKEN AT THE BASE AND WAS HOLDING THE LENS IN PLACE. ALSO STATED THAT AN APPROXIMATE 1 MM PIECE OF THE HAPTIC WING BROKE OFF AND IT WAS NOTED ON THE LENS FIELD POST INSERTION. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED, THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED, THEY DO NOT KNOW EXACTLY HOW THE TIP OF THE HAPTIC WAS BROKE OFF. IT WAS JUST A LITTLE TINY PIECE. DOCTOR WAS ABLE TO REMOVE THE PIECE AND THE LENS WAS USABLE. IT WAS AN OUTPATIENT PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176932 ↗MalfunctionMay 26, 2025Failure to Deliver; Failure to Deliver
A NON HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT DEPLOY/UNLOCK. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22084949 ↗MalfunctionMay 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS LOADING ERROR AND LENS WAS CRACKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21992684 ↗
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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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