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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non health care professional reported that during an intraocular lens (iol) implant procedure, scratch on the lens was noticed so the new unspecified lens was opened and implanted.Additional information has received and it stated that there was no patient contact and scheduled procedure completed on the same day.
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).
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.The lens was returned adhered to the inside of the lens case lid with viscoelastic.The lens had been cut into two pieces.The lens was cleaned with klrp for further evaluation.The optic had a small section missing at the edge by the cut area.No scratches were observed.The reported scratch may have been obscured by the cuts made on the optic.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified associated products were used.The root cause could not be determined for the reported scratch.The lens had been cut into two pieces.No scratches were observed.The reported scratch may have bee obscured by the cuts made on the optic.It is unknown if qualified associated products were used.The instructions for use (ifu) instructs: company foldable iol (intraocular lens) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.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 ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the company iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.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; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21303253
• Report Number: 1119421-2025-00292
• Device Sequence Number: 8169079
• Product Code: POE
• UDI-Device Identifier: 00380652405720
• UDI-Public: (01)00380652405720(17)270704(11)230706(10)15664141
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Report Date (Section B): 04/02/2025

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 Model Number: CCWET0
• Device Catalogue Number: CCWET0.175
• Device Lot Number: 15664141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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
• Patient Sex: Unknown