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

Model Number AU00T0

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  malfunction  

Event Description

A healthcare professional reported that they had a company preloaded lens inserter that appeared to be flanged out on the tip of the blue part of the inserter.They had to be very careful injecting it because it could have gotten snagged on the iris of the patient.There were no ill effects for the patient.Additional information has been requested.

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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information was provided in d.10., h.3., h.6.And h.10.The device was returned loose in the carton with the plunger fully advanced outside the nozzle tip.The plunger tip has an upper and lower flange.The plunger tip was evaluated.Both the upper and lower flange were bent.This may have been interpreted as the reported complaint.A qualified viscoelastic was provided.The root cause cannot be determined for the reported complaint.The upper and lower flanges were bent.The device was returned unsecured in the carton with the plunger fully advanced outside of the nozzle tip.It cannot be determined if the observed damage occurred during return shipment or if this was the reported complaint.The upper flange may bend during lens advancement as it is flexible.This can result if a plunger over or underride occurs.Damage to the lower flange would indicate a plunger over or underride occurred.Due to the condition of the returned sample we are unable to determine when/how the damage may have occurred.This physical appearance of the bent flanges may have been exacerbated due to being returned unsecured in the carton.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: 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: 17756554
• MDR Text Key: 323515979
• Report Number: 1119421-2023-01610
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394802
• UDI-Public: 00380652394802
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

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
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15588722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISCOVISC