Clareon SY60WF (UDI 00380652251501)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 intraocular lens is reported to crack, break, or tear during implantation, sometimes requiring lens removal or exchange. There are 79 adverse event reports naming it, with no deaths and 10 injuries. 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
- 78
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00380652251501), received between Sep 27, 2022 and Sep 28, 2026 — classified as 9 injuries, 69 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (18 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 Material18
- Break12
- Crack12
- Material Split, Cut or Torn12
- Adverse Event Without Identified Device or Use Problem7
- Failure to Deliver4
- Failure to Eject4
- Material Deformation4
Patient problems
- Insufficient Information44
- No Clinical Signs, Symptoms or Conditions28
- Blurred Vision4
- Eye Irritation2
- Capsular Bag Tear1
- Dizziness1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913147 ↗MalfunctionSep 15, 2026Break
Patient problems: Insufficient Information
MAUDE report 50775541 ↗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 left eye.
Patient problems: Visual Impairment
MAUDE report 50019375 ↗MalfunctionJun 15, 2026Material Split, Cut or Torn
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CONTINUED TO HAVE A CRACK AT THE HAPTIC OPTIC JUNCTION. COMPANY IV INJECTORS WERE REPLACED WITH NEW ONES, HOWEVER, THE ISSUE PERSISTED. A LENS LOADING IN SERVICE WAS CONDUCTED, BUT THE PROBLEM STILL OCCURRED. IT WAS ALSO STATED THAT THE LENS HAD A CRACK ADJACENT TO THE HAPTIC. THE LENS WAS IMPLANTED USING THE COMPANY IV INJECTOR, AND ALL LENS LOADING PROCESSES WERE PERFORMED CORRECTLY. THE CRACK WAS OBSERVED AFTER IMPLANTATION. THE LOCATION OF THE CRACK DID NOT WARRANT REMOVAL, AS THE RISK WAS CONSIDERED TO OUTWEIGH THE BENEFIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25505106 ↗MalfunctionApr 23, 2026Failure to Deliver; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK IN THE CARTRIDGE, & WHEN INJECTED INTO THE EYE IT WAS DAMAGED. SO, THE LENS HAD TO BE CUT OUT. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED BY THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM AND THE PATIENT CURRENT CONDITION IS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965406 ↗MalfunctionApr 17, 2026Break
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, WHEN THE LENS WAS IMPLANTED INTO THE PATIENT'S EYE, IT WAS NOTICED THAT THE HAPTIC WAS BROKEN. THE LENS WAS THEN REMOVED FROM THE PATIENT'S EYE AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. THERE WAS NO PATIENT HARM AND THE ISSUE WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913042 ↗MalfunctionMar 17, 2026Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A CRACK IN IT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617437 ↗MalfunctionMar 16, 2026Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS RIP INSIDE THE INJECTOR. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24604998 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD DISCOMFORT, DUE TO WHICH THE IOL WAS EXCHANGED FOR A NON COMPANY LENS IN A SECONDARY PROCEDURE.
Patient problems: Eye Irritation
MAUDE report 24590098 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD DISCOMFORT, DUE TO WHICH THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS REPLACED WITH SAME COMPANY DIFFERENT MODEL LENS.
Patient problems: Eye Irritation
MAUDE report 24528196 ↗MalfunctionMar 5, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION (IOL) SURGEON WAS IMPLANTED LENS WITHOUT HAPTIC. THE SURGEON EXPLANTED THE LENS AND REIMPLANTED WITH ANOTHER IOL WITH SAME PARAMETERS IN THE INITIAL PROCEDURE. THE PATIENT DIDN¿T SUFFER AND HIS CONDITION WAS GOOD. 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 24516249 ↗MalfunctionFeb 26, 2026Break
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS TORN OFF. THERE WAS PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 24456065 ↗MalfunctionFeb 23, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS WASTED/DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24415386 ↗MalfunctionFeb 16, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, HAPTICS WERE TRAPPED WITH THE TIP OF THE INJECTOR AT THE TIME OF LENS INSERTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24344557 ↗MalfunctionFeb 2, 2026Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT THE DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY THE LENS WAS DAMAGED. ADDITIONAL INFORMATION RECEIVED STATING THAT THE SCRATCHES WERE FOUND ON BOTH SIDES OF THE IOL OPTICS AND A BIT MORE RESISTANCE WHEN THE IOLS WERE BEING ADVANCED. ADDITIONAL INFORMATION RECEIVED STATING THAT THE PHYSICIAN DID NOT FIND A BURR OR ANYTHING SIMILAR IN THE CARTRIDGES.
Patient problems: Insufficient Information
MAUDE report 24236416 ↗MalfunctionFeb 2, 2026Failure to Deliver; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS GOT STUCK AND SPLIT INSIDE THE CARTRIDGE WHEN LOADING. PROCEDURE COMPLETED THE SAME DAY. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. 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 24235286 ↗MalfunctionDec 19, 2025Material Twisted/Bent; Material Twisted/Bent
A DIRECTOR OF NURSING REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE SURGEON NOTICED THAT THE HAPTIC OF THE LENS WAS TRYING TO DETACH FROM IT AFTER THE LENS WAS IMPLANTED. CONSEQUENTLY, THE SURGERY WAS COMPLETED BY REMOVING THE IOL IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23848735 ↗MalfunctionDec 5, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTICED THAT THE HAPTIC WAS OFF THE OPTIC WHEN TRYING TO PLACE THE LENS.ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE RESIDENT LOADED THE LENS TOWARD THE TOP (SMALLER) PORTION OF THE CARTRIDGE, WHICH MAY HAVE CAUSED STRESS ON THE HAPTIC (ARM). THE LENS WAS INSERTED AND THEN REMOVED DURING THE INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED THE SAME DAY WITH NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727979 ↗MalfunctionDec 4, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY IT WAS NOTICED THAT THE HAPTICS WERE MISSING FROM THE LENS. THE SURGERY WAS COMPLETED WITH BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23717115 ↗MalfunctionNov 28, 2025Material Deformation; Material Deformation
ADDITIONAL INFORMATION RECEIVED AND CONFIRMED THAT, THE LENS WAS DAMAGED PRIOR TO INSERTION.
Patient problems: Insufficient Information
MAUDE report 23672015 ↗MalfunctionNov 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE, THE LENS WAS FOUND TO BE CRACKED. THE PROCEDURE PERFORMED WAS CATARACT SURGERY INVOLVING THE IMPLANTATION OF AN INTRAOCULAR LENS. THE LENS REMAINS IMPLANTED IN PATIENT'S EYE. THERE WAS NO PATIENT HARM. A DECISION REGARDING REPLACEMENT HAS NOT YET BEEN MADE, AS THE SITUATION IS CURRENTLY UNDER OBSERVATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23614662 ↗MalfunctionOct 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS BROKEN. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23347019 ↗MalfunctionOct 17, 2025Failure to Deliver; Device Damaged by Another Device; Failure to Deliver; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS GOT STUCK IN COMPANY CARTRIDGE. AFTER THE SURGEON REMOVED IT, THE IOL CHANGED ITS SHAPE AND BECAME UNSUITABLE FOR IMPLANTATION. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED LENS OF THE SAME DIOPTER AND POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322102 ↗MalfunctionSep 12, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IOL FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAD BEEN RECEIVED AND STATED THAT, THE PHYSICIAN WAS NOT COMFORTABLE IMPLANTING IT BECAUSE IT LOOKED DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23035795 ↗MalfunctionSep 9, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS BENT AND THE LENS WAS NOT AVAILABLE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23005532 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.