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

Model Number	CNWET0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Headache (1880); Visual Impairment (2138); Eye Pain (4467)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure reported with a description of iol was cracked, when observed bilaterally this appearance remains consistent with what is seen unilaterally.The patient experienced a "water droplet appearance" that affects their central vision.New information has been received stating "water droplet appearance" that affects their central vision, headaches, bilateral eye strain.There are two medical device reports associated with this patient.This is 1 of 2.
Additional 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)(4).
Additional Manufacturer Narrative
The provided photos were reviewed.The area of interest was indicated to be the white line in the center of both photos.The haptics were indicated to be top and bottom.This would place the area of interest along the fold path.It cannot be determined if this area is damage from the photos.A video, if available would help with review of the indicated area.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The provided photos were reviewed.The area of interest was indicated to be the white line in the center of both photos.The haptics were indicated to be top and bottom.This would place the area of interest along the fold path.It cannot be determined if this area is damage from the photos.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Global quality customer affairs (gqca) conducted a call with the surgeon to discuss the patient's issues.Surgeon was familiar with expert opinion md resource.No further information has been provided.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC 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: 18137340
• Report Number: 1119421-2023-01896
• Device Sequence Number: 8055447
• Product Code: POE
• UDI-Device Identifier: 00380652405355
• UDI-Public: 00380652405355
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: 05/21/2026
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.255
• Device Lot Number: 15413214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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 IOL DELIVERY SYSTEM, CARTRIDGE.
• Patient Sex: Unknown