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

Model Number	SY60WF
Medical Device Problem Codes	Failure to Deliver (2338); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.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).
Event or Problem Description
A non-healthcare professional reported during cataract surgery with intraocular lens (iol) implant procedure, the lens got stuck in the cartridge during implementation and during subsequent manipulation, noticed that iol was damaged.The surgery was completed on same day by using company same lens model.There was no patient contact and impact.The damage to the iol was noticed after they realized that the lens was stuck in the cartridge.The lens did not get implanted and removed from the patient¿s eye.The second lens was used to complete the surgery.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.Two photos were provided showing the yellow lens model.There appears to be clinical solution on the lens.One haptic appears to be possibly bent in the gusset area.There is a linear mark (possibly a scratch or scrape) observed near the optic center.It cannot be determined from the photos if the mark was present on the anterior or posterior surface.A physical sample would be necessary to make additional confirmations.Product history records were reviewed, and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.Based on our observation of the attached photos, there appears to be a scratch/mark on the optic of the lens and clinical solution appears to be present on the lens.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).The viscoelastic indicated is not qualified for the lens/ company cartridge combination used.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The account indicated the product was not available to evaluate.It is difficult to make a final determination without evaluation of the physical sample.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information is received.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: 22176614
• Report Number: 1119421-2025-01635
• Device Sequence Number: 15403534
• Product Code: HQL
• UDI-Device Identifier: 00380652251563
• UDI-Public: (01)00380652251563(17)280311(11)240313(10)15821125
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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.240
• Device Lot Number: 15821125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/12/2025
• Date Device Manufactured: 03/13/2024
• 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: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL.; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PE-HA-VISCO 2.4% 2.0ML, LOT: XA058B-01.
• Patient Sex: Female