MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
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 that following intraocular lens (iol) implantation procedure, patient had refractive error.The lens was exchanged for an unknown advanced technology intraocular lens (atiol) 1 month and 30 days after the initial implant procedure.Clinical reason was mechanical failure of iol.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in b.5.And h.11.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.No further reports required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and reported that the iol was exchanged for the same lens model but seven diopter less power indicating the correct lens power was not implanted initially.There is no reported defect or fault with the iol.Iol implantation was technically perfect.

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 20247157
• Report Number: 9612169-2024-00909
• Device Sequence Number: 7313258
• Product Code: POE
• UDI-Device Identifier: 00380652405218
• UDI-Public: (01)00380652405218(17)260322(11)220324(10)25381032
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 03/22/2026
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.185
• Device Lot Number: 25381032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/17/2024
• Date Device Manufactured: 03/24/2022
• 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: ARGOS BIOMETER.; BETADINE.; BSS STERILE IRRIGATING SOLUTION.; CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL.; IRRIGATION AND ASPIRATION TIPS.; LIDOCAINE 1%.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MOXIFLOXACIN 1.6MG/ML.; ORA SYSTEM WITH VERIFEYE MESSAGING.; PHENYLEPHRINE 1.5%.; REPLACEMENT LENS: UNSPECIFIED ATIOL.; UTRATA FORCEP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male