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

Model Number AU00T0

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: a sample has not been received for evaluation.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.A root cause has not been identified.(b)(4).

Event Description

An ophthalmic surgeon reported that during a cataract removal with intraocular lens (iol) implant procedure, when she removed the device after implantation of the preloaded lens, a part of the plunger (a blue plastic particle) was observed in the patient's eye.The particle was removed without issues or patient impact.It was noted that the lens is correctly implanted.Additional information has been requested.

Manufacturer Narrative

Product evaluation: the device was returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted.The upper tip of the plunger is broken (not returned).Photos were provided of a blue particle in the eye, which would be compatible with the broken portion of the plunger tip.The portion was not returned for evaluation.The lens remains implanted.Viscoelastic was not provided.It is unknown if the qualified product was used.The device tip was broken upon return.The root cause for the damage cannot be determined.No other device damage was observed.It is unknown if a plunger over or underride may have occurred, which might have caused the flexible tip to break.This is atypical damage.The manufacturer internal reference number is: (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: 7016823
• MDR Text Key: 92739547
• Report Number: 1119421-2017-01294
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.255
• Device Lot Number: 12452441
• Other Device ID Number: 00380652358385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2016
• 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