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	02/24/2025
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 healthcare professional reported that during an intraocular lens implantation procedure, the inserter damaged the lens.The lens was inserted and removed during the initial procedure, an anterior vitrectomy was performed, and the lens was replaced with the company lens.
Additional Manufacturer Narrative
Only the device was returned loose in the carton.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was fully advanced.No damage was observed to the device.The lens was not returned for an evaluation.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The product investigation cannot identify the root cause the lens was not returned for an evaluation of the reported damage.Only the used device was returned.The plunger was fully advanced.It is unknown if a qualified viscoelastic was used.The ifu instructs during device preparation and implantation of the company model iq iol with the company preloaded delivery system, a 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.Information indicated that an anterior vitrectomy was performed.The company model 18.0 diopter lens was removed and replaced with a company model lens (unknown diopter).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; 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: 21663990
• Report Number: 1119421-2025-00783
• Device Sequence Number: 20724124
• Product Code: KYB
• UDI-Device Identifier: 00380652394727
• UDI-Public: (01)00380652394727(17)261003(11)231005(10)15725415
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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 Expiration Date: 10/03/2026
• Device Model Number: AU00T0
• Device Lot Number: 15725415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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 OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown