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

Model Number CNWET0

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

A non-health care reported that, following the cataract surgery with intraocular lens (iol) implant procedure, registered nurse helped insert an iol into the injector and when physician was going to inject iol into, he noticed a crack in the lens.Additional information has been requested.Additional information received and stated that, the only detail noted was that the metal plunger was not behind the lens optic but was very slightly advanced and overlapping the edge of the optic.As soon as the implant had entered the eye, there were 2 short linear cracks noted in the optic.As a result, the implant had to be removed and the surgeon loaded a replacement lens.

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)(6).

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC 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: 18091781
• MDR Text Key: 327639727
• Report Number: 1119421-2023-01877
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 00380652405232
• UDI-Public: 00380652405232
• 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
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.195
• Device Lot Number: 15516286
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female