MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. 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	Visual Disturbances (2140); Unspecified Eye / Vision Problem (4471)
Date of Event	04/26/2023
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 facility representative reported that following an intraocular lens (iol) initial implant procedure, the patient was unhappy with level of vision.Clinical reason being mentioned as mechanical complication of the lens and higher order aberration to advised contrast issues.The iol was explanted and exchanged for an unknown atiol following the secondary implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated the iol was explanted and exchanged for a different model unspecified diopter company lens following the secondary implant procedure.
Additional Manufacturer Narrative
The product was not returned for analysis.Company lens replaced with another lens.The root cause for the reported complaint could not be determined.The exchange from a company lens to a company lens, may suggest that the replacement lens model was an improved choice for the patient's vision needs.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information has been provided in b.3., and b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the patient doing well since the explant.Vision was great with replacement lens.A consumer reported stating unable to see out of the lens on pod (postoperative day) 4 following the initial surgery; mechanical complication of lens, higher order aberration/contrast issues.Pod 4 the lens was blurry.Multiple visits back and forth to ophthalmology (over 19 visits).Referred for a 2nd opinion (had to wait over 6 months for the appointment).This lens was removed and replaced.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING 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: 19870230
• Report Number: 9612169-2024-00761
• Device Sequence Number: 18087289
• Product Code: POE
• UDI-Device Identifier: 00380652405577
• UDI-Public: (01)00380652405577(17)260607(11)220609(10)25424707
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 12/05/2024

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: 06/07/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.100
• Device Lot Number: 25424707
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 08/07/2024; 10/02/2024; 11/07/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 09/05/2024; 10/30/2024; 12/05/2024
• Date Device Manufactured: 06/09/2022
• 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 INJECTOR.; MONARCH II LOADING FORCEPS.; MONARCH III CARTRIDGE D.; UNSPECIFIED VISCOELASTIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female