MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWET4
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during surgery, when intraocular lens was implanted, a scratch was noticed.In addition to scratch there seemed to be something else that was injected with the lens.The surgeon thought that it was the haptic but surgeon felt both haptics were intact.The lens and the foreign material was removed and was available for investigation.No further information expected as reporter unwilling to be contacted.
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 product was returned for analysis and the reported lens damage was observed.Foreign material was not observed.Iol loose in unknown sealed pouch along with lens case.Solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is returned, the other haptic is intact.The optic is torn/split-cut dividing the iol in two, fibers are also adhered to the solution.The lens case is intact.The rectangular foreign material shown in the photo was not observed on the returned sample.Photos provided showing 1) what appears to be foreign material on lens case lid.2) photo shows an implanted iol, there appears to be a scratch/mark on the optic.The exact location of the marks cannot be confirmed.We are unable to determine the root cause for the reported complaint "lens scratched, foreign material on lens ".The returned iol shows evidence of possible handling by the customer due to the presence of solution.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Foreign material was not observed.No determination can be made on the reported foreign material without the evaluation of the physical product, a final root cause cannot be determined based on available information.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 17085517
• Report Number: 9612169-2023-00432
• Device Sequence Number: 17664528
• Product Code: MJP
• UDI-Device Identifier: 00380652455657
• UDI-Public: 00380652455657
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 03/15/2025
• Device Model Number: CCWET4
• Device Catalogue Number: CCWET4.205
• Device Lot Number: 25281657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 08/25/2023
• Date Device Manufactured: 10/22/2021
• 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 II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown