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

Model Number AU00T0

Device Problems Unintended Ejection (1234); Device Slipped (1584); Positioning Problem (3009)

Patient Problem Capsular Bag Tear (2639)

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Attempts have been made to obtain additional information by phone and email.A completed questionnaire was not received.(b)(4).

Event Description

A facility representative reported that when an intraocular lens (iol) was being inserted into a patient's eye, the lens advanced in an uncontrolled fashion and popped out of the injector creating a hole in the posterior capsular membrane.Additional information was requested.

Manufacturer Narrative

The device and the lens were returned loose in the carton.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.No device damage or abnormalities are observed.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The lens was returned.Solution is dried on the lens.Haptic and optic damage were observed.Product history records were reviewed and the documentation indicated the product met release criteria.The viscoelastic indicated is a qualified product.The root cause for the reported ¿uncontrolled¿ advancement could not be determined.No problems were observed with the returned device.Top coat dye stain testing was conducted with acceptable results.The observed lens damage in typical of an insertion and removal.(b)(4).

Event Description

A facility representative reported that when an intraocular lens (iol) was being inserted into a patient's eye, it advanced in an uncontrolled fashion and popped out of the injector creating a hole in the posterior capsular membrane.Additional information was requested.In a follow up, a nurse reported that the lens was cut and removed from the eye during the initial procedure.Another lens was placed in sulcus and the wound was closed with a suture.No vitreous was encountered.The patient had decreased vision postoperatively.The event was considered resolved with the indicated treatment.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5656205
• MDR Text Key: 45215627
• Report Number: 1119421-2016-00736
• 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: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.235
• Device Lot Number: 12428252
• Other Device ID Number: 00380652358347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2016
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 71 YR