MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCWET0
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
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 facility representative reported with a description of multiple scratches on intraocular lens (iol).Upon visualization of scratches after implantation the surgeon needed to remove iol and implant backup iol.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.10., h.3., h.6.And h.11.The product was not returned.A photo was provided that displayed the opened lens case.The lens case lid was facing upward, displaying the product information.The base component of the lens case held the lens.There appeared to be viscoelastic on the lens.A lot of glare from overhead lights was present on the photo.The image was very blurry.One haptic appeared to be slightly extended.No further confirmations can be made based on the provided photo.A sample would be necessary for further evaluation.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of qualified associated products.No determination could be made based on our observation of the attached photo.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.File will be reopened when new information or the product is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20471735
• Report Number: 1119421-2024-02031
• Device Sequence Number: 7471752
• Product Code: POE
• UDI-Device Identifier: 00380652405775
• UDI-Public: (01)00380652405775(17)270411(11)230413(10)15618395
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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 Model Number: CCWET0
• Device Catalogue Number: CCWET0.200
• Device Lot Number: 15618395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/12/2024
• Date Device Manufactured: 04/13/2023
• 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: MONARCH II LOADING FORCEPS; MONARCH III IOL , INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 75 YR
• Patient Sex: Male