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 Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that, during intraocular lens (iol) implant procedure, the injector tip was found to be defective on the injectable lens.The implant was still usable and implanted in the patient.Additional information was requested.

Manufacturer Narrative

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

Event Description

Additional information received from nurse that, the issue was noticed during the deployment of the lens.It did not cause any harm but it had the potential.

Manufacturer Narrative

Only the device was returned loose inside the opened carton.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was fully deployed.The plunger extended beyond the nozzle tip due to being fully deployed.The anterior soft flange of the plunger tip was slightly bent backward.The flange is flexible by design to help facilitate a successful lens delivery through the device.There was no damage observed to the plunger.There was no damage observed to the device body or nozzle.A photo was provided that matched the returned product.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic information was not provided.The used device was evaluated.There was no problem found with the device or the plunger.The anterior soft flange of the plunger tip was slightly bent backward.The flange is flexible by design to help facilitate a successful lens delivery through the device.There have been no other complaints reported in the lot number.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: 14021134
• MDR Text Key: 288662632
• Report Number: 1119421-2022-00687
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394796
• UDI-Public: 00380652394796
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2022

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
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15253032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 04/12/2022; 06/09/2022
• Supplement Dates FDA Received: 05/09/2022; 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1