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

Model Number AU00T0

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: the device was returned in a bag.The plunger is oriented correctly.Viscoelastic is observed in the device.The device was returned with the plunger advanced outside of the tip.The upper portion of the plunger tip is bent down with the flange bent back.It cannot be determined if this damage occurred during delivery or return shipment.Product history records were reviewed and documentation indicated the product met release criteria.It is unknown if a qualified viscoelastic was used.Root cause: the root cause for the reported "blue particle" could not be determined.The particle was not returned for evaluation.The returned plunger was damaged.Force would be necessary to bend the thick part of the plunger tip down.It could not be determined if the damage occurred during delivery or if the damage may have occurred during return shipment as the device was returned in a bag with the plunger extended.No missing pieces were observed.There are no other complaints in this lot.(b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, after the lens was inserted, a blue particle was found on the anterior side of the iol.The surgeon removed the blue particle and the iol remained implanted.The surgeon suspects the blue particle was from the plunger.There was no patient harm.

• 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 ; 8175514979
• MDR Report Key: 10390587
• MDR Text Key: 203308342
• Report Number: 1119421-2020-01118
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: AU00T0
• Device Lot Number: 12754217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1