Clareon SY60WF (UDI 00380652251525)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 Alcon Clareon intraocular lens has 85 adverse event reports: 75 malfunctions and 10 injuries, with no deaths. The reports mostly describe haptics (the lens's side supports) breaking or detaching, and lenses scratched or cracked during insertion. Many reports lack patient details. 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
- 84
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00380652251525), received between Jul 6, 2022 and Aug 27, 2026 — classified as 9 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Break” (22 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
- Break22
- Scratched Material21
- Material Split, Cut or Torn10
- Crack9
- Failure to Deliver7
- Adverse Event Without Identified Device or Use Problem6
- Defective Device5
- Material Twisted/Bent5
Patient problems
- Insufficient Information48
- No Clinical Signs, Symptoms or Conditions31
- Blurred Vision4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Corneal Edema2
- Eye Pain2
- Visual Disturbances2
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Failure to Deliver
A non-health care professional reported that during an intraocular lens (IOL) implant procedure, lens was sticky and hard to advance.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50470800 ↗MalfunctionMay 4, 2026Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTIC BECAME CAUGHT IN THE FORCEPS AND SUBSEQUENTLY BREAK.
Patient problems: Insufficient Information
MAUDE report 25070221 ↗MalfunctionMar 20, 2026Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTICS WAS BROKEN AFTER IMPLANTING THE LENS IN THE EYE. HENCE, THEY HAVE REQUESTED ANOTHER LENS WITH SAME POWER AND COMPLETED THE SURGERY ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24647546 ↗MalfunctionMar 7, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WOULD NOT UNFOLD FOR PROPER LOADING WITH NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24539864 ↗MalfunctionFeb 27, 2026Material Deformation
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24468977 ↗MalfunctionFeb 10, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE ADVANCING LENS INTO EYE THE HAPTIC BROKEN WAS NOTICED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED WITH THE COMPANY LENS ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24304245 ↗MalfunctionJan 27, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC BROKE OFF WHILE LOADING LENS INTO CARTRIDGE. ADDITIONAL INFORMATION WAS RECEIVED THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24188338 ↗MalfunctionJan 9, 2026Failure to Deliver; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS TIGHT IN CARTRIDGE BUT WAS STILL MOVABLE. UPON INSERTING OR ADVANCING INTO EYE THE COMPANY CARTRIDGE WAS SPLINTERED AND SCRATCHED THE LENS. THE LENS HAD TO REMOVE FROM THE PATIENT'S EYE DURING INITIAL PROCEDURE AND GOT NEW ONE AND THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24022572 ↗MalfunctionJan 5, 2026Scratched Material
A PHARMACIST REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON OBSERVED THREE DISTINCT MARKS LOCATED CENTRALLY ON THE IOL, DIRECTLY WITHIN THE VISUAL AXIS. IT WAS STATED THAT THESE MARKS APPEARED CONSISTENT WITH POTENTIAL PRESSURE FROM THE INJECTOR, IN ADDITION TO THAT THE IMPLANT WAS FOUND TO BE EXTREMELY FRAGILE, TEARING VERY EASILY DURING THE MANIPULATION AND DURING SUBSEQUENT ATTEMPTS OF EXPLANTATION. HENCE, THE IOL WAS REMOVED AND REPLACED WITH AN ANOTHER IOL. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION RECIEVED AND STATED THAT DIFFUSE CORNEAL EDEMA WAS NOTED FOLLOWED BY THE INTRAOPERATIVE EXPLANTATION OF THE IOL. ON THE POSTOPERATIVE DAY 7 THE VISUAL ACTIVITY WAS RECORDED AS "COUNTS FINGERS". THE DEFECTIVE IMPLANT WAS EXPLANTED AND EXPLANTATION WAS CHALLENGING AS THE IMPLANT TORE INTO SMALL FRAGMENTS, PREVENTING REMOVAL IN A SINGLE PIECE DESPITE ATTEMPTS TO SECTION IT INTRACAMERALLY.
Patient problems: Corneal Edema
MAUDE report 23958182 ↗MalfunctionDec 19, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN OBSERVED UNDER THE MICROSCOPE LENS WAS FOUND TO BE BENT AND UNUSABLE. THE SAME MODEL LENS WAS IMPLANTED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23849327 ↗MalfunctionNov 24, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, TORN OR BROKEN HAPTIC. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING LOADING EVENT OCCURRED AND THERE WAS NO PATIENT CONTACT WITH DEVICE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. IN THE SURGEON'S OPINION, IT WAS UNKNOWN IF WHAT PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23631076 ↗MalfunctionNov 11, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A HAPTIC WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT CONTACT, AND THE SURGERY WAS ABLE TO CONTINUE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23521609 ↗MalfunctionNov 6, 2025Material Discolored; Material Discolored
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION PROCEDURE AT THE TIME OF IMPLANTING THE LENS, SOMETHING WHITE WAS EVIDENT ON THE LATERAL PART OF THE OPTIC, SO THE DOCTOR DECIDED NOT TO USE IT IN THE SURGERY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485705 ↗MalfunctionNov 5, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT THE DEFECT IN THE HAPTIC WAS IDENTIFIED DURING THE LOADING PROCESS BEFORE SURGERY, THE PROCEDURE COMPLETED ON THE SAME DAY WITH NO PATENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23478657 ↗MalfunctionNov 3, 2025Material Deformation; Material Deformation
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23450245 ↗MalfunctionNov 3, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL GOT STUCK AND COULD NOT GET THE IOL OUT OF THE CARTRIDGE COMPLETELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23446937 ↗MalfunctionOct 28, 2025Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use
A NURSE REPORTED BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS MISSING. THERE WAS NO PATIENT CONTACT AND PROCEDURE WAS COMPLETED ON THE SAME DAY. IN THE SURGEON¿S OPINION QUALITY ISSUE WITH IOL CONTRIBUTED TO EVENT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE SCRUB TECH DID NOT EVEN ATTEMPT TO LOAD THE LENS SINCE UPON INSPECTION, NOTICED THAT IT WAS MISSING A HAPTIC. IN THE SURGEON¿S OPINION PRODUCT CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402384 ↗MalfunctionSep 4, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS FOUND TO BE BROKEN OR TORN. THE LENS WAS IMPLANTED AND SUBSEQUENTLY REMOVED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH OTHER LENS. ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22962633 ↗MalfunctionAug 15, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS GOT STUCK IN THE COMPANY CARTRIDGE AND WOULD NOT ADVANCE AS EXPECTED. THE REPORTER CONFIRMED THAT THE DEVICE HAD MADE CONTACT WITH THE PATIENT'S RIGHT EYE DURING THE ATTEMPT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE IOL ATTEMPTED TO DELIVER USING COMPANY III INJECTOR AND DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD) ALONG WITH CURVED TIER FORCEPS. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 4 OF 4. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22814440 ↗MalfunctionAug 14, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC BROKE AT ITS BASE AFTER INSERTION. LENS WAS REMOVED DURING THE INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 22804126 ↗MalfunctionJul 15, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FOUND TO HAVE A DEFECT WHILE LOADING THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22508054 ↗InjuryJul 11, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT ONE WEEK POST OPERATIVE VISIT, PHYSICIAN NOTICED HAPTIC WAS NO LONGER ATTACHED TO THE IOL. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED IOL IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22477610 ↗MalfunctionJul 10, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BACK HAPTIC WAS BROKEN BEFORE LOADING. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469194 ↗MalfunctionJul 7, 2025Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTICS DID NOT OPEN WHILE LOADING AND THE SURGEON CONFIRMED UNDER THE MICROSCOPE WITH NO PATIENT CONTACT. IN THE SURGEON'S OPINION DAMAGE WAS FROM MANUFACTURER AND THE PRODUCT QUALITY ISSUE HAD CAUSED OR CONTRIBUTED TO EVENT. THE PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22412954 ↗MalfunctionJun 30, 2025Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TECH NOTICED THAT THE LENS WAS SCRATCHED. PROCEDURE COMPLETED THE SAME DAY AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357015 ↗
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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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