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	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A other health care professional reported that during an intraocular lens (iol) implant procedure, the injector would not engage the lens and allow it to be implanted.There was patient contact with the device but not the iol.The procedure was completed with an alternative lens.There was no patient harm reported.
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.An attached photo shows the pre loaded device laying on the extra label set.The plunger stop and lens have been removed.The plunger has been removed from the device and is shown laying beside the pre loaded device.The lens appears advanced into the nozzle of the pre loaded device.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in h.3., h.6., and h.10.The product was not returned.A photo was provided which showed the company preloaded device.The plunger lock and lens stop were removed.The plunger was removed from the device and was shown laying to the right of the barrel assembly.No damage observed.The barrel assembly was shown from the side.The lens was visible advanced into the nozzle entry area.Due to the side view, the trailing haptic position could not be visualized.The leading haptic appeared to be extended.This may indicate a plunger override occurred.Unable to determine viscoelastic amount from the photo.A non-qualified viscoelastic was indicated.The product was not returned.The root cause for the reported issue may be related to a failure to follow the ifu (instructions for use).A non-qualified viscoelastic was indicated.The plunger had been removed from the device in the provided photo.The plunger position in relation to the lens during advancement cannot be determined.The ifu 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.Viscoelastic amount could not be determined from the photo.The ifu also instructs: 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.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; 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: 17017195
• Report Number: 1119421-2023-00990
• Device Sequence Number: 7378225
• Product Code: KYB
• UDI-Device Identifier: 00380652394666
• UDI-Public: 00380652394666
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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 Expiration Date: 08/23/2025
• Device Model Number: AU00T0
• Device Lot Number: 15476763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 05/29/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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: Z HYLAIN
• Patient Sex: Unknown