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

Model Number AU00T0

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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 surgeon reported that a mark was on an intraocular lens (iol) after it was inserted in a patient's eye. The mark disappeared after aspiration of the viscoelastic solution. The injector is thought to have caused the mark on the iol. The surgery was completed. There was no patient harm. This is one of two reports for this facility.

Manufacturer Narrative

The device was returned. The plunger is oriented correctly. Viscoelastic is observed in the device. The plunger has been retracted to mid-nozzle. No damage is observed. The nozzle was removed and cleaned for further evaluation. Top coat dye stain testing was conducted with acceptable results. There was no interior damage observed to the coating. A photo was provided for the serial number in this file. The photo is of the lens in the eye. No fold lines are observed. The area of interest is marked with a red arrow. This appears to be loose foreign material. No other determination can be made from the photograph. Product history records were reviewed and the documentation indicated the product met release criteria. The device was evaluated and no damage was observed. The nozzle was removed and cleaned for further evaluation. Top coat dye stain testing was conducted with acceptable results. There was no interior damage observed to the coating. Based on review of the provided photo the lens is not scratched and no fold lines were observed. The area of interest is marked with a red arrow. This appears to be loose foreign material. It has been indicated the material is removed with aspiration which would support the this is loose foreign material. The material was not returned for identification testing. The origin of the material cannot be determined. There no evidence the material came from the returned device. 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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7274563
• MDR Text Key: 100431453
• Report Number: 1119421-2018-00182
• 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

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12525739
• Other Device ID Number: 00380652358309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/15/2018 Patient Sequence Number: 1