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

Model Number	MA60AC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.All product and batch history records are quality reviewed prior to product release.The file indicated the use of a qualified cartridge and handpiece.Two viscoelastics were indicated, only one was qualified for the lens/cartridge combination used.The root cause for the capsular tear could not be determined.A malfunction has not been indicated or information provided that the lens was the cause of the event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that during an intraocular lens (iol) implant procedure, the capsule tore noted and lens was removed from eye.The originally scheduled procedure was completed on same day.

• Brand Name: ACRYSOF MULTIPIECE 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: 16688723
• Report Number: 1119421-2023-00602
• Device Sequence Number: 17622628
• Product Code: HQL
• UDI-Device Identifier: 00380652552578
• UDI-Public: 00380652552578
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.225
• Device Lot Number: 12624452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH II CARTRIDGE B; MONARCH III INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown