MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	ACU0T0
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the used device was returned, loose in a large biohazard bag with the extra labelling set.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.There appeared to be dried blood at the tip.The plunger has been retracted to mid-nozzle.There was no damage observed to the barrel, load area, lens loading door, nozzle, or the tip.The blue plunger removed and evaluated.There was no damage or abnormalities noted.The plunger was reinserted into device with no problem found.The lens was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.Only the used device was returned.No damage was observed to the device or the plunger.The reported complaint of "injector failure" was not specified.The plunger was retracted upon return.The plunger position relative to the lens during delivery cannot be confirmed.It is unknown if a qualified viscoelastic was used.The instructions for use 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported during the intraocular lens implantation the injector had failed.The tip was in contact with the patient.The surgery was completed with a back up lens in the same procedure.Additional information has been requested.

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH 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: 14488617
• Report Number: 1119421-2022-01111
• Device Sequence Number: 20164198
• Product Code: KYB
• UDI-Device Identifier: 00380652395250
• UDI-Public: 00380652395250
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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: 01/11/2025
• Device Model Number: ACU0T0
• Device Lot Number: 15333850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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
• Patient Age: 65 YR
• Patient Sex: Unknown