MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL W/AUTONOME DELIVERY SYSTEM; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNAET0
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, peripheral area of lens optics found damaged after implantation.Subsequently the lens was removed during initial procedure and completed using a non company iol.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was added in d.9., h.3., h.6.And h.11.The product was returned for analysis and damage was observed to the intraocular lens (iol) optic.Iol returned in three segments inside a specimen container immersed in solution.Both haptics are intact.One segment of the optic is cracked/fractured and scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint "peripheral area of lens optics found damaged".The iol was returned in three segments, which is consistent with lens having been explanted.The product was subject to handling and the reported optic damage was highlighted post implantation.The reported complaint is lacking in relevant information such as associated cartridge, handpiece used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the product contributed to the event.In addition to this, all intraocular lenses (iols) are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.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 HYDROPHOBIC IOL W/AUTONOME DELIVERY SYSTEM
• 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: 20000296
• Report Number: 9612169-2024-00813
• Device Sequence Number: 15286813
• Product Code: POE
• UDI-Device Identifier: 00380652406208
• UDI-Public: (01)00380652406208(17)261008(11)221010(10)25507984
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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 Model Number: CNAET0
• Device Catalogue Number: CNAET0.150
• Device Lot Number: 25507984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 08/19/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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: PROVISC OVD.
• Patient Sex: Unknown