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

Model Number AU00T0

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

A sample product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are not other complaints in the lot.(b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the iol became stuck in the delivery system.There was patient contact, but no harm to the patient.The procedure was completed that day with backup product.Additional information was requested.

Manufacturer Narrative

The device and the lens was returned separately in the bottom portion of the blister tray inside the carton.The mylar label has been removed from the device exterior.The mylar adhesive is still present on the device exterior.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lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.No damage was observed.The lens was returned folded in a small white gauze material.Solution was dried on the lens.One haptic is torn through the optic/haptic junction (still attached).The optic is split/cracked.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The lens was not stuck in the device upon return.The root cause cannot be determined for the complaint of "iol was stuck and cannot be properly implanted".The lens was returned outside the device with broken/torn haptic damage and split optic damage.No damage was observed to the device.The plunger was retracted upon return.The plunger position in relation to the lens during advancement cannot be determined.The dfu instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken/torn haptic or other negative outcome, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.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, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8646659
• MDR Text Key: 146494321
• Report Number: 1119421-2019-00774
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12585840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 08/08/2019
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1