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

Model Number AU00T0

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: the device with the lens was returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger is at the optic edge.The lens is advanced into the nozzle entry area.The trailing haptic is on top of the plunger.The leading is stretched along the right side of the nozzle.This would indicate the plunger and lens may have been retracted.The lens has not been delivered from the device.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.There have been no similar complaints reported in the lot number.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause for the reported issue could not be determined.The lens was not inserted and removed as it was returned still in the nozzle of the device.A plunger override was not observed; however the haptic positions may indicate the plunger/lens were retracted.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the iol was inserted and removed.There was contact with the patient and the procedure was completed that day.Additional information was reported that the iol was not used.It did not engage.

• 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: 10006003
• MDR Text Key: 189465747
• Report Number: 1119421-2020-00727
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/28/2020

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 Expiration Date: 03/31/2021
• Device Model Number: AU00T0
• Device Lot Number: 12611492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2018
• 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
• Patient Age: 81 YR