MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	AU00T0
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Eye Pain (4467)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported that during an intraocular lens (iol) implant procedure, reported with a description of loader shot at force.New information has been received includes posterior capsular tear, severe pain, lens was explanted during initial procedure.Additional information has been received from the surgeon stating that prognosis remains guarded.Patient has not had the next surgery yet but should within the next few weeks.The problem was that she does not want to have any more surgery unless it was under general anesthesia and most likely need to have a vitrectomy with wound revision followed by secondary lens implantation.Patient was stable but her intraocular pressure (iop) has been difficult to control and surgeon concerned about further vision loss due to this.
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
A qualified viscoelastic was indicated.The product was discarded by the reporting facility.Information was provided that the viscoelastic amount used was "what was already in the syringe".It cannot be determined from this statement if the device was filled with ovd (ophthalmic viscosurgical device) per the ifu.It was also indicated that the ovd was not at room temperature.Fully insert the ovd cannula, perpendicular to the device, through the viscoelastic port, located in the lens stop portion of the device.Fill the device until ovd can be observed flowing to the ¿fill-to¿ line on the nozzle tip.This will require approximately 0.2 ml of ovd.Only use an company ovd qualified for use with the company pre-loaded delivery system that has been allowed to come to the operating room temperature.After the lens has been advanced to the ¿fill-to¿ line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.No part of the lens should exit the nozzle prior to insertion through the incision.Once the lens is in position at the ¿fill-to¿ line, it should be implanted within 3 minutes.Proceeding with implantation of a misfolded trailing haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome.The reporting facility has not provided any further information.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received from the non-health care professional stating after discussion with the provider at the other facility, the patient was reconsidering having the follow up procedure at our practice but we are still in the planning stages.I¿ve referred her to one of the other providers here who may be able to do everything in one procedure but she has not had that evaluation yet.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 18137344
• Report Number: 1119421-2023-01894
• Device Sequence Number: 8055449
• Product Code: KYB
• UDI-Device Identifier: 00380652394727
• UDI-Public: 00380652394727
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Report Date (Section B): 01/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2025
• Device Model Number: AU00T0
• Device Lot Number: 15553709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Female