Clareon SY60WF (UDI 00380652251518)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Clareon SY60WF intraocular lens from Alcon has 79 adverse event reports naming its identifier, describing mostly scratched, cracked or broken lens material, sometimes requiring lens removal or replacement during surgery; 7 reports mention injuries and 72 mention malfunctions, with no deaths. There are no recalls naming this device. Reports fell to 13 in the last 12 months from 33 the prior year.
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
- 82
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00380652251518), received between Feb 24, 2022 and Sep 30, 2026 — classified as 8 injuries, 74 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (25 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material25
- Break16
- Material Split, Cut or Torn8
- Adverse Event Without Identified Device or Use Problem6
- Material Twisted/Bent6
- Crack5
- Device Damaged by Another Device4
- Defective Device3
Patient problems
- Insufficient Information43
- No Clinical Signs, Symptoms or Conditions33
- Blurred Vision4
- Capsular Bag Tear2
- Visual Impairment2
- Conjunctivitis1
- Corneal Edema1
- Endophthalmitis1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Split, Cut or Torn
A healthcare professional reported during intraocular lens (IOL) implant procedure, the surgeon noticed optical part of IOL had cracks after the IOL was implanted into the eye. The lens was explanted during initial procedure. The procedure was completed on same day. There was no patient harm.Additional information received via regulatory agency stating that the IOL appeared normal, with no abnormality observed by the naked eye. After implantation into the patient's eye, a distinct scratch was observed in the central area of the IOL under the microscope and procedure was completed by using another unspecified lens.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945173 ↗MalfunctionSep 30, 2026Dent in Material
A health care professional reported that during cataract surgery with intraocular lens (IOL) implantation, a stripe was observed on the lens optic after it was implanted. Consequently, the implanted lens was removed, and another lens was placed during the same surgery. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50943064 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that following intraocular lens (IOL) implantation, the patient experienced blurry vision. Consequently, the lens was removed and replaced with an advanced technology intraocular lens (ATIOL) during a secondary procedure.Additional information has been requested but is not available at the time of this report.
Patient problems: Blurred Vision
MAUDE report 50897319 ↗MalfunctionSep 25, 2026Scratched Material
A nurse reported that during an intraocular lens (IOL) implant procedure, IOL was scratched and 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 50896953 ↗MalfunctionSep 24, 2026Break
A non-healthcare professional reported that, during an intraocular lens (IOL) implantation procedure, a torn trailing haptic was noticed on the lens during loading, with no patient contact. The procedure was completed on the same day with another unspecified lens. Patient was in very good condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884755 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that, during the intraocular lens implantation procedure, a capsular tear occurred. The lens was wasted, and the surgery was completed with a backup IOL. There was no further patient impact. No additional medical or surgical intervention was required, and the patient was not hospitalized as a result of the event.
Patient problems: Capsular Bag Tear
MAUDE report 50232803 ↗MalfunctionJun 8, 2026Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DAMAGED HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PRODUCT WAS DAMAGED PRIOR TO INSERTION BUT COULD NOT SEE DETAIL OF DAMAGE OF HAPTIC UNTIL UNDER MICROSCOPE IN PATIENTS' EYE. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH SAME MODEL AND DIOPTER COMPANY LENS. THERE WAS NO FURTHER PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25429267 ↗MalfunctionMay 4, 2026Dent in Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THEY NOTICED A SMALL TEAR ON THE EDGE OF THE LENS, LENS SCRATCHED. THEY TOOK THE LENS OUT AND UNSPECIFIED NEW LENS WAS USED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25069964 ↗MalfunctionApr 24, 2026Scratched Material
A CONSUMER REPORTED THAT THE LENS WAS SCRATCHED. 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 24977309 ↗MalfunctionApr 1, 2026Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SCRATCH ON THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24756591 ↗MalfunctionMar 25, 2026Break; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF HAPTIC BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS CAME OUT HEAVILY DAMAGE FROM THE SHOOTER, AND IT WAS VISIBLE IMMEDIATELY AFTER INSERTING THE LENS. THEY NOTICED 2 CRACKS IN THE OPTIC, AND IT DID NOT CENTER THE LENS PROPERLY. COMPANY REPLACEMENT LENS WAS USED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24684073 ↗MalfunctionMar 23, 2026Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661176 ↗MalfunctionMar 13, 2026Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE LENS WAS NOT IMPLANTED BECAUSE IT WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24590916 ↗MalfunctionFeb 2, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT SCRATCHED ON ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24235124 ↗MalfunctionNov 27, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THE HAPTIC WAS BROKEN, THE LENS WAS IMPLANTED IN THE PATIENT EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23665228 ↗MalfunctionNov 17, 2025Break; Break
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS RIPPED AND TORN WHILE INSERTING THE LENS INTO THE EYE.
Patient problems: Insufficient Information
MAUDE report 23570358 ↗MalfunctionOct 24, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED AS HAPTIC TORN WITH NO PATIENT CONTACT. SURGERY CONTINUED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23376429 ↗MalfunctionOct 23, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS TWISTED AND DEFORMED WHILE LOADING THE IOL IN THE CARTRIDGE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TRAILING HAPTIC WAS TWISTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23365194 ↗MalfunctionOct 15, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THEY NOTICED A SCRATCH OR MARK ON OPTIC. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY USING ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23279151 ↗MalfunctionSep 19, 2025Break; Break
A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE HAPTIC WAS FOUND TORN (DAMAGE TO THE IOL LOOP) WHEN INSERTED IN THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY USING UNSPECIFIED REPLACEMENT LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23095860 ↗MalfunctionSep 15, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WOULD NOT BENT.
Patient problems: Insufficient Information
MAUDE report 23051074 ↗InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNEXPECTED OPTICAL SURPRISE. THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS OPTICAL SURPRISE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 23004303 ↗MalfunctionJul 31, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTICS BROKEN OFF. ADDITIONAL INFORMATION WAS RECEIVED STATING HAPTICS BROKEN OFF WHEN PUSHED OFF FROM THE SHOOTER. THERE WAS PATIENT CONTACT. LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE.
Patient problems: Corneal Edema; Insufficient Information
MAUDE report 22676797 ↗MalfunctionJul 22, 2025Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS PLACED IN THE PATIENT¿S EYE, IT APPEARED THAT THERE WAS A DEFECT NOTED ON THE IMPLANT BY THE SURGEON, AND THE HAPTIC WAS SLOW TO OPEN OR UNFOLD. AFTER MULTIPLE ATTEMPTS TO REMOVE THE FOREIGN OBJECT, IT WAS DETERMINED THAT THE DEFECT WAS IN THE LENS ITSELF POSSIBLY A CRACK IN THE LENS AND THE LENS WAS SUBSEQUENTLY REMOVED BY THE SURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22566857 ↗MalfunctionJul 18, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS FOUND TO HAVE TORN OR BROKEN HAPTIC. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE LENS REMAINED IN THE DELIVERY SYSTEM. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 22548267 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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