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

Model Number AU00T0

Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)

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

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that an intraocular lens was stuck in an injector during the surgery.The device touched the patients eye.There was no clinical consequence for the patient as a back up device was used and the surgery was completed.

Manufacturer Narrative

The device with the lens was returned loose in the carton.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Only a small amount of viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.The device tip has severe damage (bent, twisted, stress lines, aneurysm).The lens was returned on the exterior of the device barrel.The optic is scratched.All product and batch history records are quality reviewed prior to product release.A qualified viscoelastic was used.The lens was returned placed on the exterior of the device.The device tip has extreme damage.The root cause of the event may be related to a failure to follow the dfu.Inadequate viscoelastic was observed in the device.The dfu instructs: fill the device until viscoelastic can be observed flowing to the line on the nozzle tip.This will require approximately 0.2 ml of viscoelastic.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to underride the lens.The extreme tip damage most likely is the result of the indicated "several attempts" to remove the lens from the device.Information provided in the file indicates that: an implant remained stuck in injector, with no possibility to remove it after several attempts.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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8941597
• MDR Text Key: 155989403
• Report Number: 1119421-2019-01379
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: AU00T0
• Device Lot Number: 12596691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2018
• 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