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	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the used device was returned loose in a large biohazard bag.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was fully deployed, with tip of blue plunger extended beyond the nozzle tip of the device.The plunger was removed and evaluated.There was no damage or abnormalities observed.The plunger was reinserted into the device and was secure at the starting point.Product history records were reviewed and the documentation indicated the product met release criteria.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.The root cause cannot be determined for the reported complaint.The returned condition of the product does not match the reported complaint of "would not advance through cartridge".Only the used preloaded device was returned.The plunger was fully deployed.There was no lens returned, and no damage observed to the device or plunger.This evidence suggests that a lens delivery was completed.However, it is unknown if possibly the lens had been removed from the device prior to return shipment.It is unknown if a qualified viscoelastic was used.The instructions for use ifu instructs: during device preparation and implantation of the company lens 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 lens did not advance through the cartridge.The tip of the device was in contact with the patient.The surgery was completed on the same day with a back up lens.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: 14488804
• Report Number: 1119421-2022-01112
• Device Sequence Number: 4736262
• Product Code: KYB
• UDI-Device Identifier: 00380652395144
• UDI-Public: 00380652395144
• 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: 10/19/2024
• Device Model Number: ACU0T0
• Device Lot Number: 15293160
• 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: 10/21/2021
• 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: 74
• Patient Sex: Unknown