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	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
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 health care professional reported that during an intraocular lens (iol) implant procedure, small defects were observed on the optic edge after implantation.Lens was explanted in secondary procedure.There was no patient harm.Additional information was requested.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product has not returned.Two photos were provided.One photo was identified for this file.A label shown on this image indicated mshd smile eyes.This photo displayed a partial view of a monitor screen.A yellow lens model was shown inside the eye.Two metal surgical instruments were shown tilting the lens toward the camera.The one metal instrument tilted the lens from below, showing the optic edge.A red circle was placed onto the area of the customer¿s concern.The image was too blurry inside the circled area in order to make a determination.A glare from the overhead lights was also visible and what appeared to be solution was around the edges of the optic.The clarity of the photo was too poor to make a determination for the reported damage.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause cannot be determined for the reported event.The explanted lens was not returned for an evaluation.Photos were provided.The photo with the label of mshd smile eyes was identified for this file.Based on our observation of the attached photos, the clarity is too blurry to make a determination.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.It is unknown if a qualified viscoelastic was used.The ifu (instructions for use) instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.It is unknown if adequate viscoelastic was used.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 an company ovd qualified for use with the company pre-loaded delivery system that has been allowed to come to the operating room temperature.Information indicated that the lens was explanted and exchanged.The explanted lens was not available to return.The replacement lens information was not provided.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 or the sample 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; 246 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: 21754031
• Report Number: 1119421-2025-00894
• Device Sequence Number: 12817109
• Product Code: KYB
• UDI-Device Identifier: 00380652394840
• UDI-Public: (01)00380652394840(17)270423(11)240424(10)15842825
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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 Model Number: AU00T0
• Device Lot Number: 15842825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/08/2025
• Date Device Manufactured: 04/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male