MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 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).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, a scratch around a lens area was found after insertion.The scratch seemed to expand in 5 to 6 o'clock direction.The surgery was completed without product replacement; the lens had remained in the patient's eye.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis.Only video were returned.The reported complaint was observed on the returned video.Received video shows intraocular lens (iol) implantation.Device preparation is not shown.As the iol exits the cartridge tip it appears to be folded incorrectly and unfolds in a vertical position instead of horizontal.The iol is manipulated into position with a surgical tool and a scratch/mark can be seen on the optic.The healthcare professional (hcp) makes an attempt to remove the scratch/mark, but it is not removed.Based on our observation of the attached photo, there appears to be a scratch/mark on the iol optic.The origin of the observed scratch/mark cannot be confirmed based on the returned video alone and without evaluating the physical product.The product was subject to handling and the reported damage was highlighted post implantation.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20143558
• Report Number: 9612169-2024-00865
• Device Sequence Number: 12861281
• Product Code: HQL
• UDI-Device Identifier: 00380652251587
• UDI-Public: (01)00380652251587(17)250308(11)211015(10)25290758
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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 Expiration Date: 03/08/2025
• Device Model Number: SY60WF
• Device Lot Number: 25290758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/12/2024
• Date Device Manufactured: 10/15/2021
• 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 MONARCH IV IOL, INJECTOR; MONARCH III IOL, CARTRIDGE C; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown