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 Codes	Blurred Vision (2137); Eye Pain (4467)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that after surgery, the patient experienced vision blurred and sore eye.Initial three piece iol implant was explanted and replaced with anterior chamber lens following the secondary implant procedure.As per the surgeon¿s opinion the haptic of sulcus lens rubbing on iris/ugh (uveitis-glaucoma-hyphema).Originally scheduled procedure completed the same day.Patient's issues resolved.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution and blood are dried on the lens.The lens was cleaned with klrp for further evaluation.The lens has a scratch that goes across the posterior surface of the optic.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a non-qualified cartridge.A handpiece and viscoelastic was indicated that is qualified with a qualified cartridge.The product investigation could not identify a root cause for the reported complaint.Information was provided by the surgeon that the issue was most likely caused by the haptic of sulcus lens rubbing on the iris/uhg (uveitis-glaucoma-hyphema).The instructions for use (ifu) states that the company is a posterior chamber lens.Information was provided that the company lens, 20.0 diopter lens was replaced with a company lens, 18.0 diopter anterior chamber lens.The manufacturer internal reference number is: (b)(4).

• 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: 20742765
• Report Number: 1119421-2024-02268
• Device Sequence Number: 8613510
• Product Code: HQL
• UDI-Device Identifier: 00380652552523
• UDI-Public: (01)00380652552523(17)270925(11)220927(10)15499545
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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 Model Number: MA60AC
• Device Catalogue Number: MA60AC.200
• Device Lot Number: 15499545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• 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: ANTERIOR CHAMBER PMMA IOL.; DUOVISC OVD.; MONARCH III IOL , CARTRIDGE C.; MONARCH III IOL INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female