MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

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	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during the intraocular lens (iol) implant procedure, the lens was blocked.The surgery was completed with replacement lens.There was no discomfort for the patient.Additional information has been requested.
Additional Manufacturer Narrative
The device with the lens was returned loose in the carton.The plunger lock and lens stop were removed.The plunger was oriented incorrectly.Viscoelastic was observed in the device.The plunger was advanced into the nozzle and has overrode the lens.The plunger override was most likely interpreted as the complaint.The lens was slightly advanced and still in the lens loading area.The leading haptic was at the far end of the loading area.The trailing haptic was folded onto the optic along the left side of the plunger.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause for the reported complaint cannot be determined.A plunger override was observed.The lens was in the loading area.The plunger override was most likely interpreted as the complaint.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.Plunger override may occur: due to rapid advancement faster than the (instructions for use) ifu recommend rate.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 19370427
• Report Number: 1119421-2024-00992
• Device Sequence Number: 18019863
• Product Code: HQL
• UDI-Device Identifier: 00380652394857
• UDI-Public: 00380652394857
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: 02/06/2026
• Device Model Number: AU00T0
• Device Lot Number: 15585673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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: DUOVISC
• Patient Sex: Unknown