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

Model Number AU00T0

Device Problems Positioning Problem (3009); Physical Resistance/Sticking (4012); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the device with the lens was returned.The plunger is oriented correctly.Inadequate viscoelastic is observed in the device.The plunger has been advanced under the lens.The lens is advanced almost to the fill line.The trailing haptic is misfolded under the optic.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.Viscoelastic was not provided.It is unknown if the qualified product was used.A plunger underride was observed.The root cause may be related to a failure to follow the directions for use.Inadequate viscoelastic was observed in the device.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implantation procedure, the iol would not deploy and the haptic went sideways.There was patient contact.Additional information was provided indicating felt resistance during injection.No damage to the patient.

• 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: 10246277
• MDR Text Key: 198690066
• Report Number: 1119421-2020-00951
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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: 12738805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2019
• 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