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

Model Number AU00T0

Device Problem Contamination (1120)

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

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

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 are no other complaints in the lot.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, a foreign material like a crimped nylon thread was confirmed on the optic of the iol after it was inserted in the patient's eye.The material was removed with forceps.There was no harm to the patient.Additional information was requested.

Manufacturer Narrative

A dvd was provided and the device was returned loose in the carton.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.No fibers were observed in the device.No damage was observed.The lens remains implanted.The reported foreign material was returned taped to the bottom of a petri dish.It appears to be a long bluish fiber.Sent to particle lab for identification testing.The sample was analyzed using microscopic fourier transform infrared spectroscopy (micro ft-it).The sample was identified as cotton.The dvd was viewed.The device preparation was not shown.The device tip comes into view at the bottom of the screen.The device tip is placed into the incision up to the wound guard.Only the leading haptic is in view.The leading haptic is in a question mark shape.The lens can only be observed entering the eye.The travel through the tip is not visible.A long fiber can be observed on the posterior surface after the lens is delivered into the eye.The origin of this fiber cannot be determined from the viewpoint shown on the dvd.The device was evaluated and no fibers were observed.A fiber was returned in a petri dish.The particle lab identified a light blue 6mm fiber, which per microscopic fourier transform infrared spectroscopy (micro ft-it) was identified as cotton.The origin of the fiber cannot be determined from the viewpoint shown on the dvd.Cotton is a common contaminate found in a many environments.Origin is unknown.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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7947050
• MDR Text Key: 123246444
• Report Number: 1119421-2018-01466
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: AU00T0
• Device Lot Number: 12481662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2016
• 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