Clareon SY60WF (UDI 00380652251464)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 has 40 adverse event reports mentioning its identifier. Most describe the lens breaking, scratching, bending, or tearing—often haptics—during implantation, and a few mention refractive surprise after placement. The reports cite 5 injuries and no deaths. There are no recalls for 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
- 40
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00380652251464), received between Jun 7, 2022 and Aug 7, 2026 — classified as 4 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- Scratched Material8
- Defective Device6
- Material Twisted/Bent5
- Device Contamination with Chemical or Other Material3
- Adverse Event Without Identified Device or Use Problem2
- Crack2
- Device Dislodged or Dislocated2
Patient problems
- Insufficient Information24
- No Clinical Signs, Symptoms or Conditions13
- Blurred Vision2
- Corneal Edema1
- Corneal Stromal Edema1
- Endophthalmitis1
- Excessive Tear Production1
- Eye Injury1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Scratched Material
Patient problems: Insufficient Information
MAUDE report 50173838 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Visual Impairment
MAUDE report 25638550 ↗MalfunctionMay 15, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WAS NOT FOLDED CORRECTLY (ALSO REPORTED AS TRAILING HAPTIC FOLDED WRONG).
Patient problems: Insufficient Information
MAUDE report 25184112 ↗MalfunctionApr 15, 2026Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WAS CRUNCHY. COULD NOT BE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24885411 ↗MalfunctionApr 4, 2026Failure to Deliver; Dent in Material
A HEALTHCARE PROFESSIONAL REPORTED THAT, AT THE IMPLANTATION MOMENT, IOL PASSED THROUGH THE CARTRIDGE WITH A SHOOTING SOUND. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE DEFECT WAS DETECTED DURING THE SURGERY. THERE WAS PATIENT CONTACT. THERE WAS NO HARM TO THE PATIENT. THE SURGERY WAS COMPLETED, AND AFTER IMPLANTATION A CREASE-LIKE MARK WAS NOTICED ON THE OPTICAL PART OF THE IOL. THERE WAS NO REUSING OF THE PRODUCT. THERE WAS NO ADDITIONAL MEDICAL MANIPULATION AND THE PATIENT WAS STABLE. AFTER THE SURGERY, THE DISTANCE VISION OF THE OPERATED EYE WAS 0.9. THE PATIENT WAS DISCHARGED WITH IMPROVEMENT. THERE ARE MULTIPLE PATIENTS REPORTED ALONG WITH THIS FILE. THIS FILE IS FOR (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24784872 ↗MalfunctionApr 1, 2026Material Deformation
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DAMAGED AND IT WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24756003 ↗MalfunctionMar 6, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS TORN OR BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24528204 ↗MalfunctionMar 3, 2026Material Split, Cut or Torn
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS LOADED SMOOTHLY AND WITHOUT ISSUE AND THE FORCEP TIPS WERE NOT PLACED ON THE IOL AND ANY TIME. THE IOL WAS ADVANCED INTO THE CARTRIDGE BY GENTLY SEATING THE IOL IN THE CARTRIDGE WITH THE CURVED TYING FORCEPS WITH TIPS UP. ONCE THE IOL WAS INSERTED, A HALF MM TEAR WAS NOTED ON THE OUTER PERIMETER OF THE IOL, IN THE AREA WHERE THE TRAILING HAPTIC ATTACHES TO THE LENS THE DAMAGED IOL WAS LEFT IN PLACE AND THE PROCEDURE WAS COMPLETED. THE IOL REMAINED IMPLANTED, THE CARTRIDGE WAS MISTAKENLY THROWN AWAY. THE CARTRIDGE WAS CHECKED INSIDE WITH A KOCH SPATULA THAT NOTED NO ROUGHNESS INSIDE OF THE CARTRIDGE AND THE CARTRIDGE WAS ALSO EXAMINED UNDER THE MICROSCOPE WITH NO DAMAGE NOTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497330 ↗MalfunctionFeb 13, 2026Failure to Deliver
ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE INCIDENT OCCURRED DURING THE PROGRESSION OF THE IMPLANT, WITHIN THE INJECTION SYSTEM / INSIDE THE CARTRIDGE AND THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24333372 ↗MalfunctionFeb 9, 2026Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS SCRATCHED. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER UNSPECIFIED BACKUP 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 24292335 ↗MalfunctionJan 12, 2026Product Quality Problem; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FOUND TO BE STIFF BUT MOVABLE. THE LENS WAS ADVANCED INTO EYE AND ONE HAPTIC WAS NOT UNFOLDED PROPERLY EVEN WHEN WAITING WITH TIME AND MANIPULATION. EVERYTHING ELSE WAS FINE. HAD TO REMOVE IT FROM THE EYE AND GET A NEW LENS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT HAPTIC WAS NOT UNFOLDING WITHIN THE EYE (LEADING OR TRAILING, UNSPECIFIED). THE LENS WAS INSERTED AND REMOVED ON THE SAME DAY. IN THE SURGEON¿S OPINION BAD LENS WAS THE REASON. THERE WAS NO IMPACT TO THE PATIENT. THE SURGEON¿S PROGNOSIS WAS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24049994 ↗MalfunctionDec 19, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED VIA REPLY CARD THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN SO, IT WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23849977 ↗MalfunctionDec 12, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS SLIGHTLY OUT OF THE WAY FROM THE IMPLANTABLE CARTRIDGE, AFTER THE IOL WAS INSERTED INTO THE CARTRIDGE AND IMPLANTED INTO THE EYE ADHESION OF IOL HAPTIC WAS RESOLVED BY THE IA (IRRIGATION/ASPIRATION) TIP. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23790824 ↗MalfunctionOct 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS IMPLANTED ACCORDING TO THE OPERATING PROCEDURES. AFTER IMPLANTATION, CRACKS WERE FOUND AROUND THE IOL. DUE TO THE CRACKS BEING LOCATED AROUND THE IOL AND OBSTRUCTED BY THE IRIS, IT DID NOT AFFECT VISION, LIGHT PASSAGE, OR THE STABILITY OF THE LENS. IOL UNDERWENT MORPHOLOGICAL CHANGES DURING FOLDING, RESULTING IN CRACKS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357210 ↗MalfunctionJul 18, 2025Break; Break
A NURSE REPORTED THAT BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS ARM WAS TORN. THE PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22545898 ↗MalfunctionApr 24, 2025Break; Break
A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK WAS FOUND IN A TRAILING HAPTIC DURING IOL IMPLANTATION. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH ANOTHER REPLACEMENT IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21900490 ↗MalfunctionMar 18, 2025Break; Break
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF TWO INTRAOCULAR LENSES WERE ATTEMPTED TO BE IMPLANTED. TWO HAD HAPTICS TORN OFF. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT UPON IMPLANTATION IT WAS NOTED THAT THE PLUNGER OF THE LENS LOADER WAS SHEARING OFF THE HAPTICS OF THE BOTH LENSES. THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE. THE SURGERY WAS COMPLETED WITH THE THIRD INTRAOCULAR LENS WITH OUT ANY DAMAGE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634851 ↗MalfunctionMar 18, 2025Break; Break
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF TWO INTRAOCULAR LENSES WERE ATTEMPTED TO BE IMPLANTED. TWO HAD HAPTICS TORN OFF. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT UPON IMPLANTATION IT WAS NOTED THAT THE PLUNGER OF THE LENS LOADER WAS SHEARING OFF THE HAPTICS OF THE BOTH LENSES. THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE. THE SURGERY WAS COMPLETED WITH THE THIRD INTRAOCULAR LENS WITH OUT ANY DAMAGE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634850 ↗MalfunctionMar 17, 2025Scratched Material; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 21623203 ↗InjuryMar 3, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
ADDITIONAL INFORMATION HAS RECEIVED, AND IT STATES THAT ISSUE OCCURRED AT THE POINT OF PINCHING OF THE LENS WAS NOT VISIBLE. THE LENS CAME OUT WITHOUT HAPTICS. THEY IMPLANTED IOL INTO THE EYE WITHOUT HAPTICS, THEN HAD TO EXPLANT IT AND CHANGE IT TO A SIMILAR IOL. THE LENS CAME LOOSE, TEARING OFF THE HAPTIC. PROBABLY THE HAPTIC WAS PINCHED BY THE INJECTOR PLUNGER IN THE CARTRIDGE NOZZLE.
Patient problems: Blurred Vision; Corneal Edema
MAUDE report 21502871 ↗MalfunctionFeb 24, 2025Failure to Fold; Material Twisted/Bent; Failure to Fold; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WOULD NOT FOLD AND THE HAPTIC BAD.
Patient problems: Insufficient Information
MAUDE report 21445081 ↗MalfunctionNov 27, 2024Crack; Crack
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS LOADED WITHOUT ISSUE, LENS WAS EXPLANTED IN INITIAL PROCEDURE DUE CRACK WAS NOTICED AFTER IMPLANT. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20799462 ↗MalfunctionSep 19, 2024Scratched Material; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTICED A SCRATCH ON LENS ONCE IT WAS IMPLANTED AND STATED IT COULD HAVE HAPPENED DURING LOADING. THERE WAS A PATIENT CONTACT AND PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED, DAMAGE TO THE LENS HAPPENED DURING LOADING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20256464 ↗InjuryAug 20, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS ANTERIOR DISLOCATION OF THE LENS, AND THE LEADING HAPTIC ON THE LENS WAS TORN OR APPEARED CUT. THE LENS WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL INTRAOCULAR LENS 7 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20001466 ↗MalfunctionJul 5, 2024Scratched Material; Scratched Material
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED SCRATCHES AT INTRAOCULAR LENS (IOL) EDGES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 4.
Patient problems: Insufficient Information
MAUDE report 19680765 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.