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

Model Number AU00T0

Device Problem Folded (2630)

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

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported while using a preloaded intraocular lens (iol) delivery system, the lens folded out in the incision and the lens was removed.A backup lens was used to complete the procedure.Additional information was requested.

Manufacturer Narrative

The device was returned in loose in a plastic bag.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted just behind the wound guard.No damage or abnormalities are observed.The lens was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause for the reported "iol folded out in the incision" could not be determined.No problem was found with the returned device.It is important to keep the wound guard securely against the eye and fully advance the plunger for proper lens delivery.(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: 7145254
• MDR Text Key: 95820810
• Report Number: 1119421-2017-01468
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: AU00T0
• Device Lot Number: 12501621
• Other Device ID Number: 00380652358408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Date Device Manufactured: 10/25/2016
• 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