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	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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 loading or priming the intraocular lens scratched by the injector.There was no patient contact.The procedure was completed with the another lens on the same day.Additional information has been requested.
Additional Manufacturer Narrative
The device and the lens were returned in the blister tray, inside the carton.The plunger lock and lens stop have been removed.The plunger was oriented correctly.No viscoelastic was observed in the device.The plunger was retracted back in the loading area.The lens was returned outside the device adhered by viscoelastic to the main body just above the serial number on the device.Viscoelastic was dried on the lens.The optic has deep scrape marks and cracks on the posterior side in the travel path of the plunger.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The reported lens damage was observed.The root cause for the reported complaint appears be related to a failure to follow the instructions for use (ifu).No viscoelastic was observed in the device.The ifu instructs 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 a company model ovd qualified for use with the company pre loaded delivery system that has been allowed to come to the operating room temperature.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become stuck in the device.The ifu instructs: take at least 7 seconds to gently fold the iol by advancing the plunger forward in one smooth, continuous motion until the front edge of the optic is even with the fill to line on the nozzle.Do not allow any portion of the lens to exit the nozzle tip.At this position the blue spring will contact the clear main body.It is important to not advance the plunger abruptly to fold the iol as improper folding and lens damage may occur.Due diligence has been performed in an attempt to obtain further information on this event.The facility has not responded to requests for follow up information.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• 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; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21513164
• Report Number: 1119421-2025-00580
• Device Sequence Number: 11874487
• Product Code: KYB
• UDI-Device Identifier: 00380652394772
• UDI-Public: (01)00380652394772(17)261107(11)231109(10)15749721
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: AU00T0
• Device Lot Number: 15749721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 06/11/2025
• Date Device Manufactured: 11/09/2023
• 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 LOADING FORCEPS.
• Patient Sex: Unknown