MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during intraocular lens (iol) implantation, there was absence of part of the haptic and the lens remains implanted with no patient impact.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was not returned.A photo was provided of the implanted single-piece lens.One haptic was visible held by a instrument over the optic.The end of the haptic tip was missing.This appeared to be caused by a casting issue (bubble).A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The root cause for the reported issue was determined to be manufacturing related.The lens remains implanted.Based on review of the provided photo, a small part of the haptic tip was missing.This appeared to be a casting issue.All lenses are 100 percent inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met alcon¿s release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22801417
• Report Number: 1119421-2025-02262
• Device Sequence Number: 13001909
• Product Code: HQL
• UDI-Device Identifier: 00380652251488
• UDI-Public: (01)00380652251488(17)280204(11)240206(10)15795667
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.200
• Device Lot Number: 15795667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/19/2025
• Date Device Manufactured: 02/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC OVD; MONARCH III IOL CARTRIDGE D
• Patient Age: 64 YR
• Patient Sex: Male