Clareon SY60WF (UDI 00380652251471)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 intraocular lens implanted in the eye during cataract surgery. Most of the 58 reports describe the lens being damaged before or during implantation — scratched, cracked, split or broken, sometimes blocked in its cartridge and pushed out of the eye — along with reports of blurred or impaired vision. There were 6 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
- 58
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00380652251471), received between May 9, 2022 and Jun 8, 2026 — classified as 6 injuries, 52 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material15
- Break10
- Defective Device9
- Material Split, Cut or Torn6
- Adverse Event Without Identified Device or Use Problem5
- Crack5
- Failure to Deliver3
- Material Deformation3
Patient problems
- Insufficient Information40
- No Clinical Signs, Symptoms or Conditions14
- Blurred Vision4
- Visual Impairment3
- Endophthalmitis2
- Corneal Edema1
- Dizziness1
- Eye Irritation1
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Material Deformation
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, LENS BLOCKED IN THE CARTRIDGE AND WAS PUSHED OUT DAMAGED OUTSIDE THE PATIENT EYE. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 25427855 ↗MalfunctionMay 22, 2026Material Deformation
A NURSE REPORTED WITH THE DESCRIPTION DAMAGED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25256899 ↗MalfunctionMay 5, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A GLISTENING IN THE IOL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO IMPACT TO THE PATIENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083458 ↗MalfunctionApr 28, 2026Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THE LENS WAS OPENED, GOT SCRATCHED, LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25017219 ↗MalfunctionMar 10, 2026Material Twisted/Bent
ADDITIONAL INFORMATION RECEIVED AND STATED THAT PROCEDURE WAS COMPLETED ON THE SAME USING SAME MODEL SAME COMPANY LENS. THERE WAS PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24556030 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS IMPLANTATION, PATIENT WAS ABSOLUTELY DISORIENTED AND CAN NOT WORK AND SURGEON TARGETED FOR NEAR FOR INTRAOCULAR LENS (IOL). PATIENT ALSO COMPLAINED OF DIZZINESS AND LIGHTHEADEDNESS AT WORK AND FELT FOREIGN BODY SENSATION SURGEON AIMED AT -1.75 AT PATIENT REQUEST AND ON TARGET. SURGEON TRIED TRIAL FRAME TO SHOW PATIENT CHANGE IT MADE PATIENT DIZZY AND DISORIENTED, THEN SURGEON PLACES TRIAL CONTACT -2.00 AND PATIENT REPORTED BETTER VISION AND REPORTED NO DIZZY OR DISORIENTATION. PATIENT DECIDED FOR IOL EXCHANGE IN RIGHT EYE. SURGEON SUGGESTED THAT SHE WILL NEED READERS AFTER SURGERY AND PATIENT AGREED TO IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Dizziness; Eye Irritation
MAUDE report 24494416 ↗MalfunctionJan 2, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION STATED THAT HAPTIC WAS FOUND CRACK AFTER IMPLANTATION. THE LENS WAS EXPLANTED AND REPLACED WITH A BACKUP LENS ON THE SAME DAY AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943281 ↗MalfunctionDec 30, 2025Break; Scratched Material; Break; Scratched Material
A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT IOL PITTING WAS NOTICED IN CENTRAL AREA AFTER IMPLANTING IOL IN THE BAG AND HAPTIC OPTIC JUNCTION TEAR. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS REMAINED IMPLANTED. POSTOPERATIVE OPTIC HAPTIC JUNCTION TEAR WAS NOT APPRECIATED UNDER SLIT LAMP AND PITTING LOOKED LESS EVIDENT AS WELL. THE PATIENT IS DOING FINE ON POSTOP DAY 1 AND NOT NOTICING ANY SYMPTOMS, ABOUT TO SEE HIM ON POW 2 APPOINTMENT. PATIENT HAD POST CRVO (CENTRAL RETINAL VEIN OCCLUSION) RIGHT EYE, PROGNOSIS WAS POOR. VISION WAS OK POSTOPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 23921591 ↗InjuryDec 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH POOR VISION. THE LENS WAS EXCHANGED FOR ANOTHER COMPANY LENS WITH DIFFERENT DIOPTER 9 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL BREAKDOWN. ACCORDING TO SURGEON¿S PROGNOSIS IT WAS GOOD. THE PATIENT ISSUES WERE RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 23901417 ↗MalfunctionNov 11, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BROKE DURING INSERTION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23521527 ↗MalfunctionNov 6, 2025Break; Break
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN DURING PLACEMENT AND THE IMPLANT WAS CHANGED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485253 ↗MalfunctionSep 19, 2025Break; Break
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE HAPTIC WAS INTACT AND NOT TORN OR BROKEN. THE ISSUE WAS LIMITED TO A CRACK IN THE IOL ITSELF. THE SURGEON NOTICED THE CRACK AFTER THE IOL WAS INSERTED AND POSITIONED. CONSEQUENTLY, THE IOL WAS REMOVED DURING SAME PROCEDURE. THERE WAS NO HARM
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23095858 ↗MalfunctionAug 7, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BROKE OFF INSIDE CARTRIDGE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22740295 ↗MalfunctionJul 28, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) WHEN LOADING THE LENS, SOMETHING WAS PREVENTING IT FROM ADVANCING. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22637718 ↗MalfunctionJul 22, 2025Inaccurate Delivery; Device Dislodged or Dislocated; Scratched Material; Inaccurate Delivery; Device Dislodged or Dislocated; Scratched Material
A PHARMACIST REPORTED THAT DURING A LEFT EYE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PLACEMENT FAILURE OCCURRED. THE IMPLANT GOT STUCK DURING DEPLOYMENT IN THE INCISION. THE SURGEON HAD TO REMOVE IT WITH PLIERS DURING INITIAL PROCEDURE, BUT THE OPTIC WAS MARKED. THEN THE SURGEON DECIDED TO USE A BACK-UP LENS TO AVOID OPTICAL DEFECTS LINKED TO THE MARKS ON THE IMPLANT. IT WAS REPORTED THAT THIS WAS DUE TO MISHANDLING OF THE DEVICE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22562483 ↗MalfunctionJul 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS PLACED IN THE PATIENTS EYE IT APPEARED AS THOUGH THERE WAS A DEFECT NOTED ON IMPLANT BY SURGEON. 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 THEN REMOVED BY THE SURGEON. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553825 ↗MalfunctionJul 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK FOUND TO BE NOTED DURING THE INSERTION. THE REPORTERS ASSUMING THAT IT MIGHT BE USER ERROR, HOWEVER IT COULDN'T RULE OUT IF IT COULD POSSIBLY BE A PRIOR LENS ISSUES EITHER. THE LENS HAD TO BE REMOVED FROM THE PATIENT AND THEN INSERTED A NEW LENS. ADDITION INFORMATION WAS REQUESTED AND NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22381871 ↗MalfunctionMay 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS PLACED IN THE PATIENTS EYE IT APPEARED AS THOUGH THERE WAS A FIBER OR HAIR BEHIND THE LENS. 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. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22112043 ↗MalfunctionMay 23, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DEFECTIVE LENS WITH SCRATCH ON LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079127 ↗MalfunctionMay 22, 2025Break; Break
A PHARMACIST REPORTED WITH A DESCRIPTION OF BROKEN HAPTIC IN THE INJECTOR.
Patient problems: Insufficient Information
MAUDE report 22070108 ↗MalfunctionApr 25, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN. THE LENS WAS IN PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 1 OF 2 FILES.
Patient problems: Insufficient Information
MAUDE report 21910466 ↗MalfunctionApr 22, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC BROKEN WHILE LOADING. ADDITIONAL INFORMATION RECEIVED STATING THAT TECH LIKELY DID NOT REALIZE HAPTIC WAS BROKE WHEN LOADING. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21885165 ↗MalfunctionApr 1, 2025Break; Break
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21739728 ↗InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULDN'T TOLERATE LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LENS WAS EXCHANGED FOR COMPANY LENS MODEL AFTER 2 MONTHS. THE PATIENT WAS NOT ABLE TO READ DUE TO EDEMA AFTER LENS EXCHANGE.
Patient problems: Blurred Vision; Corneal Edema
MAUDE report 21643637 ↗MalfunctionMar 17, 2025Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT DEPLOY FROM THE CARTRIDGE PROPERLY. LENS WAS BACKED OUT FROM INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21626388 ↗
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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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