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	Scratched Material (3020)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during a cataract extraction with an intraocular lens (iol) implant procedure, doctor noticed a mark or scuff on the lens once inserted into the patient eye.The lens was removed and replaced with new lens on the same day.Additional information was requested, but further no information was available.
Additional Manufacturer Narrative
The product was not returned.The cartridge used was not provided.A company handpiece was indicated with a qualified viscoelastic.The qualified handpiece for company lenses is the company handpiece.The root cause may be related to a failure to follow the ifu (instructions for use).The company handpiece is the qualified handpiece for company lenses.Per the ifu (instructions for use): company foldable intraocular lenses are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the intraocular lens and potential complications during the implantation process.The ifu (instructions for use) also instructs to completely fill the cartridge with ovd (ophthalmic viscosurgical device) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd (ophthalmic viscosurgical device) in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd (ophthalmic viscosurgical device), which may result in damage.Follow the section regarding directions for use for information on the maximum allowed time for the intraocular lens to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in intraocular lens damage.Ifu (instructions for use) note: during lens loading and insertion, do not allow the company intraocular lens to remain in a folded condition within the selected intraocular lens delivery system for more than 3 minutes prior to completing insertion into the capsular bag.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating there was no patient harm.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• 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: 16436179
• Report Number: 1119421-2023-00350
• Device Sequence Number: 19617062
• Product Code: POE
• UDI-Device Identifier: 00380652405843
• UDI-Public: 00380652405843
• 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
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.235
• Device Lot Number: 15404713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 02/25/2023; 04/10/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/24/2023; 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• 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: MONARCH II FORCEPS; MONARCH III, INJECTOR; PROVISC
• Patient Age: 67 YR
• Patient Sex: Female