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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Blurred Vision (2137); Capsular Bag Tear (2639)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that after intraocular lens (iol) implantation, the patient experienced that the near visual acuity was lacking.The surgeon tried to explant the lens later but could not do it because of issues with the capsule.Ultimately vitrectomy was done and had to leave the original implant in the patient's eye.Additional information was received.The consumer went to another eye doctor and was told that he does not have a vivity lens implanted.This doctor took a video of the lens and sent it to company sales representative who verified by video the lens did not look like a company model lens.However, in the iol card shared the serial number is for company model lens.The consumer also did not like the lack of near vision he had in the left eye, so surgeon attempted r&r to replace with another model company lens, but the patient developed posterior capsular tear, or pc rent so the r&r was aborted and the company model lens remains implanted.The patient developed two small retinal tears which were repaired by a retinal doctor.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
The product was not returned.A video was provided.The video was reviewed frame by frame.Although difficult to see on the video there were points where the company lens center ring characteristic were visible.The company lens ring characteristic are difficult to discern with top-lighting.The light needs to be at a very specific angle to view from the top.The company lens ring characteristic displays more clearly with bottom projected lighting.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint near vision issue.The product was not returned.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.A video was provided.Although difficult to see on the video there were points where the company lens center ring characteristic were visible.New information was provided that the lens was not explanted.A vitrectomy was performed and the lens remains implanted.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
The patient had significant amount of capsular phimosis and the bag was too tight to get the iol out.The posterior capsule formed a rent in the attempted iol exchange and the lens could not be explanted.The patient was told before surgery that the lens exchange might not be possible.Therefore, the lens remains implanted.

• 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: 18837144
• Report Number: 1119421-2024-00418
• Device Sequence Number: 12586276
• Product Code: POE
• UDI-Device Identifier: 00380652405713
• UDI-Public: 00380652405713
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.170
• Device Lot Number: 15346421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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: AMVISC.; MONARCH II LOADING FORCEPS.; UNSPECIFIED CARTRIDGE OTHER THAN MONARCH.; UNSPECIFIED INJECTOR OTHER THAN MONARCH.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male