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

Model Number CCWET0

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.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 Description

A facility representative reported that during an intraocular lens (iol) implant procedure, it was noticed that there was defect/crack in lens.The iol was explanted during initial procedure.Additional information has been received stating the iol was exchanged for same model company lens.

Manufacturer Narrative

The lens was returned adhered by solution to the non-serialized side of the lens case lid (lens case base not returned).Solution was dried on the lens.The optic was torn, split, cracked, and cut into two portions, typical of insertion and removal.Complaint and product history records were reviewed and documentation indicated the product met release criteria.The file indicated the use of a qualified cartridge and handpiece.The file indicated the use of a viscoelastic that is not qualified for the product combination used.The root cause for the reported complaint appears to 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 a 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
• Type of Device: 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: 18552225
• MDR Text Key: 333357334
• Report Number: 1119421-2024-00132
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 00380652405744
• UDI-Public: 00380652405744
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.185
• Device Lot Number: 15431705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AMVISC; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Age: 72 YR
• Patient Sex: Male