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 Codes	Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/26/2024
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implantation procedure, he had to widen the incision for every suspect device used.The surgeon stated that the usual incision size was 2.4 mm, but this wasn't enough for the suspect device, so he had to widen the incision to 2.5 to 2.6 mm to insert the cartridge tip into the patient's eye.There was patient contact, but no impact on the patient as the cataract operation was completed without any problems after the incisions were widened.There are seven medical device reports associated with this complaint.This report is 2 of 7.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).Reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information was added in d.10.And h.11.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated viscoelastic information was not provided.The root cause cannot be determined for the reported complaint.The facility discarded the sample.A root cause cannot be determined without physical examination of the product.It is unknown if the tip was damaged during delivery.It is unknown if qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the iol with the 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.Nozzle manufacturing is a validated operation, with specifications that are maintained and documented.No changes have been made for the manufacturing of ultrasert nozzles.Supplier manufacturing records as well as their certificate of compliance verify the dimensional measurements are within specifications.Ultrasert devices have two nozzle sizes depending on the diopter of the lens.The 27.5 d to 30.0 d iols are provided with the c-size nozzle denoted by a c on the top of the nozzle.Prior to lens implantation confirm the following: an appropriate incision is made for the corresponding nozzle size; the lens is properly positioned; and the haptics are properly folded.Then, insert the nozzle tip into the incision as far as needed to facilitate lens implantation, using the depth guard as the insertion limit, and aim the nozzle tip at the anterior capsule opening.Information was provided that the surgeon used a non-company 2.4 mm knife, but has to widen the incision to 2.5 to 2.6 mm.Company representatives have been working with the facility to determine the cause of the issue.A trial of an company knife is being conducted.These are the only complaints of this type for this device.Facility is going to do a trial use of an company knife.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Corrected information was added in b.2.And h.6.(fda product problem code has been updated).The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 20291284
• Report Number: 1119421-2024-01890
• Device Sequence Number: 7208655
• Product Code: KYB
• UDI-Device Identifier: 00380652394727
• UDI-Public: (01)00380652394727(17)261125(11)231127(10)15756843(21)15756843084
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/18/2024

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 Model Number: AU00T0
• Device Lot Number: 15756843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 10/22/2024; 11/20/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/23/2024; 11/18/2024; 12/18/2024
• Date Device Manufactured: 11/27/2023
• 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: 2,4 MM MANI KNIVES.; RED MANI KNIFE 2,2 MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown