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	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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 that during an intraocular lens (iol) implant procedure, it was observed that a chunk of the iol was missing from the edge of the optic.The haptics were intact but it a visible piece of the iol was gone.The iol was then removed and the backup was placed with no further intervention required.Additional information has been requested and received stated that there was no patient harm and the surgeon prognosis was good, no further complication was anticipated.
Additional Manufacturer Narrative
The lens was not returned for analysis.Only the empty lens case was returned in the carton with the packaging inserts and the open peel pouch.There is no damage observed to the lens case or the locking arm mechanism.The lens case functions as intended.The file indicated the use of a qualified cartridge and handpiece.The viscoelastic indicated is not qualified for the product combination used.The root cause for the reported complaint may be related to failure to follow the ifu.The file indicated the use of a viscoelastic that is not qualified for the product combination used.The ifu instructs that an 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 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: 16830492
• Report Number: 1119421-2023-00795
• Device Sequence Number: 7125250
• Product Code: POE
• UDI-Device Identifier: 00380652405799
• UDI-Public: 00380652405799
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/20/2023

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: 01/23/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.210
• Device Lot Number: 15338614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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 DELIVERY SYSTEM, INJECTOR.; HEALON.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Patient Age: 68 YR
• Patient Sex: Unknown