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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device with the lens was returned loose in a large biohazard sample bag.The lens stop and plunger lock were removed.Viscoelastic was observed in the device.Upon return the plunger was observed to be reinserted in the device incorrectly and advanced into the nozzle entry area.The plunger was engaged against the optic edge.The leading haptic was straight.The trailing haptic was folded onto the anterior optic surface.The plunger was removed and evaluated.No damage was observed.The plunger was reinserted inside the barrel correctly for evaluation.No plunger anomalies were observed.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause for the reported complaint of "plunger stuck" cannot be determined.The used device was inspected.The plunger was in the nozzle entry and engaged to the trailing optic edge.Upon return, the plunger was observed to be oriented incorrectly in the device.It cannot be determined if the plunger may have been inadvertently retracted outside of the device and reinserted incorrectly by the customer.Although the plunger orientation cannot be ruled out as a potential cause, it is unlikely that the device was manufactured incorrectly.Plunger placement is conducted with a plunger/main body assembly fixture.The fixture by design ensures the proper orientation and placement of the plunger in the device.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that, during intraocular lens (iol) implant procedure, the plunger of delivery system got stuck.There was a patient contact reported.Additional information was 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: 13092573
• Report Number: 1119421-2021-02480
• Device Sequence Number: 17191588
• Product Code: KYB
• UDI-Device Identifier: 00380652395243
• UDI-Public: 00380652395243
• 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): 12/28/2021

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: 07/11/2024
• Device Model Number: ACU0T0
• Device Lot Number: 15228778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC
• Patient Sex: Unknown