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

Model Number	MN60AC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Iritis (1940); Visual Disturbances (2140); Eye Pain (4467)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure,her vision was very dark as if there was a huge shadow in her vision.It was very red and painful.After 4 days the dark area resolved, but her vision was very distorted and has not changed since.Retina specialist said she had a bubble in her retina and needed injections.Patient had 3 months of eye injections that did not improve patient vision.Since her surgery, patient iritis has been flaring up and her pressures have ranged from 27-35 which is being treated with drops and oral medication.Patient believes her bag was damaged and therefor lens is in sulcus.The new surgeon plans to place a new lens either in the sulcus or in the anterior chamber depending on how surgery goes.Additional information was requested and received stating the lens was explanted in secondary procedure and additionally vitrectomy procedure was performed.Her symptoms were still ongoing at the time of report as the vision was still wavy and ongoing glaucoma.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.The reporter was the patient.Consumer states that they had surgery in (b)(6) 2023 and they believe there was a surgical complication that the surgeon is not admitting.Consumer was treated for retinal issues after the surgery.Consumer also stated they have a history of iritis and a family history of glaucoma.Since the surgery, the iritis has been flaring up and pressures have ranged from 27-35 which is being treated with drops and oral medication.Consumer thinks lens was implanted in the sulcus instead of the bag per the second opinion they received.The lens was explanted and replaced with a non-company iol.Patient currently being rerated for a retina issue that is ongoing as well as the glaucoma.File will be reopened if new information is received.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: 19582480
• Report Number: 1119421-2024-01185
• Device Sequence Number: 11645207
• Product Code: HQL
• UDI-Device Identifier: 00380655095140
• UDI-Public: (01)00380655095140(17)250114(11)200116(10)15004517(21)15004517022
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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 Expiration Date: 01/14/2025
• Device Model Number: MN60AC
• Device Catalogue Number: MN60AC.215
• Device Lot Number: 15004517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/24/2024
• Date Device Manufactured: 01/16/2020
• 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: BRIMONIDINE TID.; DIAMOX 250MG.; DUREZOL TID.; LI61AO 20.5D.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female