MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCWET0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A facility representative reported after implantation of intraocular lens (iol), a crack or torn on lens noticed.The lens was removed during initial and replaced with same model lens.There was no patient harm.
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the iol.Iol returned pressed down into well area of iol case base.Solution is dried on the iol.Both haptics are intact.The optic is scratched/marked-rejectable with loose fibers.The product investigation could not identify a root cause for the reported complaint ¿lens was cracked/torn¿.The product was subject to handling and damage to the lens was highlighted post implantation.The returned iol shows evidence of handling by the customer due to the presence of solution dried on the iol.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage (scratched/marked - rejectable optic) would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.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 LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16960382
• Report Number: 9612169-2023-00374
• Device Sequence Number: 12110511
• Product Code: POE
• UDI-Device Identifier: 00380652405720
• UDI-Public: 00380652405720
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: 03/21/2025
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.175
• Device Lot Number: 25289679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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 III IOL DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown