MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60AT
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2023
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 non healthcare professional reported that, during intraocular lens implantation surgery, the lens was scratched.Hence the lens was explanted and replaced with another lens in the same procedure.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
There was no patient harm.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The lens model is qualified for use in the company cartridge only.A non-qualified cartridge and viscoelastic were indicated.The associated handpiece is qualified when used with a qualified associated product combination.The root cause for the reported complaint is most likely related to a failure to follow the instructions for use (ifu).A non-qualified cartridge and non-qualified viscoelastic were indicated.The ifu instructs: company foldable intraocular lenses (iol)s 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 follow up attempts were made for additional information.No further information has been provided.If the sample or additional information becomes available, the file will be reopened and updated.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: 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: 18203480
• Report Number: 1119421-2023-01981
• Device Sequence Number: 7345727
• Product Code: HQL
• UDI-Device Identifier: 00380652555814
• UDI-Public: 00380652555814
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2024

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: SA60AT
• Device Catalogue Number: SA60AT.205
• Device Lot Number: 15475959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 01/22/2024
• Initial Report FDA Received Date: 11/24/2023
• Supplement Report FDA Received Date: 01/10/2024; 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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 II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown