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 Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: the device and the lens were returned separated.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has fully advanced outside of the device tip.The tip has an aneurysm on the right side.The lens was returned adhered to the outside of the device with viscoelastic.One haptic is folded in on the anterior surface of the optic.No lens damage observed.All product and batch history records are quality reviewed prior to product release.A qualified viscoelastic was indicated.The root cause for the reported plunger override could not be determined.The device was not returned in the reported condition.The lens was outside of the device.The device tip was damaged.This damage may indicate the plunger/lens was not in a proper position for advancement.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the iol malfunctioned while trying to advance the lens.Additional information was provided by the initial reporter that the problem was plunger override.There was contact with the patient and the procedure was completed with a new lens.

• 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: 10190177
• MDR Text Key: 196944650
• Report Number: 1119421-2020-00892
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12741218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2019
• 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
• Patient Age: 73 YR