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

Model Number AU00T0

Device Problem Entrapment of Device (1212)

Patient Problems Prolapse (2475); No Code Available (3191)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

The sample has been received by a company representative and is route to the manufacturing site for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.(b)(4).

Event Description

An ophthalmic surgeon reported that sometimes the plunger tip on the preloaded intraocular lens (iol) delivery system gets caught on the iris as she is withdrawing it from the eye post lens implantation.On the day of the report, this occurred during the first case of the day on a patient's left eye, causing the iris to prolapse out of the incision, leading to a small hole in the iris sub-incision during this process.The patient had a very shallow anterior chamber and the incision was made temporally.A suture was needed to close the incision as the iris was not staying inside the eye.A (b)(6) drug was also used to help bring the pupil down.On the subsequent cases of the day, the surgeon changed the plane at which she was holding the device on withdrawal (flattened out rather than staying steep down on the iris) and this seemed to help; no additional incidents of this nature occurred in the following four cases that she completed.Additional information has been requested.There are two medical device reports associated with this facility for this issue.This report represents the event involving the patient on the date of the report.

Manufacturer Narrative

The device was returned.The plunger is oriented correctly.Viscoelastic is observed throughout the device.The plunger has been retracted.No damage or abnormalities were observed.The lens remains implanted.A qualified viscoelastic was indicated.The root cause for the reported event could not be determined.The returned device was evaluated, and no damage or abnormalities were observed.(b)(4).

• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6867797
• MDR Text Key: 86251889
• Report Number: 1119421-2017-01133
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.215
• Device Lot Number: 12512168
• Other Device ID Number: 00380652358309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 11/10/2017
• Supplement Dates FDA Received: 12/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2016
• 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
• Treatment: DISCOVISC OVD 1ML
• Patient Outcome(s): Other; Required Intervention