Clareon SY60WF (UDI 00380652251495)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens · Class 3 · Implant
Quick summary
This Alcon Clareon SY60WF is a foldable plastic lens implanted in the eye during cataract surgery. The 62 reports mostly describe the lens being scratched, cracked, torn or broken during handling and implantation, sometimes forcing surgeons to remove and replace it, plus a few cases of eye inflammation (endophthalmitis), blurred vision and corneal swelling. Four reports involved injuries and no deaths were reported. 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
- 62
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00380652251495), received between Aug 19, 2022 and Sep 26, 2026 — classified as 3 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (14 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 Material14
- Break11
- Material Split, Cut or Torn10
- Crack6
- Failure to Deliver5
- Material Twisted/Bent5
- Adverse Event Without Identified Device or Use Problem3
- Defective Device2
Patient problems
- Insufficient Information35
- No Clinical Signs, Symptoms or Conditions28
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Capsular Bag Tear1
- Endophthalmitis1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2026Break
Patient problems: Insufficient Information
MAUDE report 50907386 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
A healthcare professional reported that, following intraocular lens implantation surgery, the lens did not achieve the intended refractive target due to a power/diopter-related issue. Hence the lens implanted in the patient's eye was removed to change the lens power and replaced with unspecified lens in a secondary procedure.Additional information has been requested but is not available at the time of this report.There are two medical reports associated with same patient. This file belongs to the right eye.
Patient problems: Visual Impairment
MAUDE report 50019374 ↗MalfunctionJun 11, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION HAPTIC WAS TORN. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25475580 ↗MalfunctionJun 3, 2026Device Damaged by Another Device
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IT WAS OBSERVED THAT THE LENS WAS DAMAGE BY THE INJECTOR, AND THE CRACK WAS NOTICED AFTER THE LENS WAS IMPLANTED. THE CRACK WAS LOCATED WHERE THE INJECTOR TOUCHED THE LENS. THE LENS WAS SUBSEQUENTLY REMOVED DURING INITIAL PROCEDURE AND THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25374444 ↗MalfunctionMay 21, 2026Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25241596 ↗MalfunctionApr 21, 2026Product Quality Problem
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING ONE OF THE HAPTIC'S WAS DEFECTIVE NOTED WHILE OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939414 ↗MalfunctionApr 6, 2026Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN RECEIVED THE PHYSICIAN REMOVED THE EXTRA HAPTIC ON THE SAME DAY. THE LENS REMAINS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24791667 ↗MalfunctionMar 5, 2026Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOTICED TO BE SCRATCHED UPON INSERTION INTO PATIENT'S EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED SURGERY WAS COMPLETED WITH SAME MODEL LENS.
Patient problems: Insufficient Information
MAUDE report 24516253 ↗MalfunctionFeb 5, 2026Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE DEFECTIVE/SCRATCHED AND WAS INSERTED AND SUBSEQUENTLY REMOVED WITHIN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24268799 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT THE CAPSULE WAS COMPROMISED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE.
Patient problems: Capsular Bag Tear
MAUDE report 24003559 ↗MalfunctionJan 7, 2026Material Split, Cut or Torn
ADDITIONAL INFORMATION RECEIVED AS ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE INTRAOCULAR LENS WAS CRACKED. THE PROXIMAL HAPTIC WAS FOUND TO HAVE A FRACTURE AT ITS JUNCTION WITH THE OPTIC. ACCORDING TO THE OPERATIVE NOTE, THIS WAS NOTICED AT THE TIME OF INJECTING THE LENS INTO THE CAPSULAR BAG. THE SURGEON REPORTS THAT THE DAMAGE LIKELY OCCURRED DURING THE LOADING PROCESS. A BACKUP LENS WAS SUBSEQUENTLY USED TO COMPLETE THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 23988966 ↗MalfunctionDec 26, 2025Scratched Material; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE LENS WAS SCRATCHED/BENT. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PHYSICIAN WAS UNSURE ON WHAT CAUSED THE SCRATCH ON THE LENS, BUT THEY SUSPECT THE CARTRIDGE TO BE DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 23896896 ↗MalfunctionDec 19, 2025Device Damaged Prior to Use; Material Split, Cut or Torn; Device Damaged Prior to Use; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF BROKEN INTRAOCULAR LENS (IOL). THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23849820 ↗MalfunctionDec 18, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN PLACING THE FIRST LENS, THERE HAD IMMEDIATELY BEEN AN ISSUE AND IT HAD TO BE REMOVED. THE ISSUE WITH THE FIRST ONE WAS THAT THE TRAILING HAPTIC HAD BEEN CRACKED AND THE LEADING HAPTIC HAD BEEN DEFECTIVE IT HADN'T BEEN SHAPED RIGHT. THE BACKUP LENS HAD BEEN COMPLETELY CEMENTED INTO THE CARTRIDGE AND HAD NOT BUDGED. THE PROCEDURE WAS COMPLETED WITH A NON COMPANY LENS ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23840048 ↗MalfunctionDec 18, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN PLACING THE FIRST LENS, THERE HAD IMMEDIATELY BEEN AN ISSUE AND IT HAD TO BE REMOVED. THE ISSUE WITH THE FIRST ONE WAS THAT THE TRAILING HAPTIC HAD BEEN CRACKED AND THE LEADING HAPTIC HAD BEEN DEFECTIVE IT HADN'T BEEN SHAPED RIGHT. THE BACKUP LENS HAD BEEN COMPLETELY CEMENTED INTO THE CARTRIDGE AND HAD NOT BUDGED. THE PROCEDURE WAS COMPLETED WITH A NON COMPANY LENS ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23840045 ↗MalfunctionDec 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INTRAOCULAR LENS (IOL) WAS TORN WHILE BEING PLACED IN THE EYE. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23725947 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DEVELOPED A FUNGAL ENDOPHTHALMITIS INFECTION IN THE EYE. THIS CONDITION HAS CAUSED SIGNIFICANT DISCOMFORT AND ADVERSELY AFFECTED THE PATIENT EYE HEALTH. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT AFTER ABOUT ONE AND A HALF MONTHS FOLLOWING CATARACT SURGERY, THE PATIENT BEGAN EXPERIENCING MILD BLURRINESS IN THE OPERATED EYE. OVER THE NEXT TWO TO THREE WEEKS, THE BLURRINESS GRADUALLY WORSENED. THE PATIENT EXPERIENCED MILD HAZE. INTRAOCULAR PRESSURE WAS SLIGHTLY HIGH. A RETINA SPECIALIST WAS CONSULTED, WHO DIAGNOSED THE CONDITION AS FUNGAL ENDOPHTHALMITIS IN THE RIGHT EYE AND RECOMMENDED PARS PLANA VITRECTOMY (PPV) SURGERY. THE PROCEDURE HAS BEEN PERFORMED TWICE SO FAR, BUT THE EYE HAS NOT YET FULLY RECOVERED. MULTIPLE LABORATORY TESTS ON EYE SAMPLES HAVE CONFIRMED THE PRESENCE OF INFECTION BEHIND THE IMPLANTED LENS. THE PATIENT HAD NO PRIOR HISTORY OF SUCH INFECTIONS, STRONGLY SUGGESTING THAT THE INFECTION DEVELOPED AFTER LENS IMPLANTATION. THE TREATING DOCTOR HAS INDICATED THAT, IF THERE IS NO IMPROVEMENT IN THE PATIENT¿S CONDITION, REMOVAL OF THE IMPLANTED LE
Patient problems: Blurred Vision; Endophthalmitis
MAUDE report 23568078 ↗MalfunctionNov 12, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE HAPTIC WAS NOTED TO BE BROKEN OFF AS LENS WAS ADVANCED INTO THE CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT AND THE PROCEDURE COMPETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23533425 ↗MalfunctionNov 6, 2025Product Quality Problem; Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23487083 ↗MalfunctionNov 6, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS DAMAGED WHILE BEING IMPLANTED. IT FELT TIGHT DURING IMPLANTATION. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE LENS HAD BEEN PARTIALLY IMPLANTED, BUT THEN THE SURGEON STOPPED THE IMPLANTATION AND REMOVED THE LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23486108 ↗MalfunctionJul 31, 2025Break; Break
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED A BROKEN HAPTIC. THE LENS WAS INTACT BEFORE INSERTING INTO CARTRIDGE, BROKEN HAPTIC NOTICED AFTER LENS IMPLANTATION. HENCE THE LENS WAS REMOVED AND REPLACED WITH A NEW LENS DURING THE SAME PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22674869 ↗MalfunctionJul 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THERE WAS A CRACK IN THE MIDDLE OF THE LENS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22468506 ↗MalfunctionJun 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS CRACKED. THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATIN THAT THE LENS WAS CRACKED SOMETIME BETWEEN LOADING AND INSERTION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299150 ↗MalfunctionJun 5, 2025Failure to Fold; Failure to Deliver; Failure to Fold; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF IMPLANT STUCK IN THE CARTRIDGE, FAULTY FOLDING. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22153090 ↗MalfunctionMay 23, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED AFTER INSERTION OF THE LENS. LENS WAS REMOVED IN INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACK UP LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22077811 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.