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

Model Number AU00T0

Device Problem Positioning Problem (3009)

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

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There is one other complaint in the lot.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the lens came out sideways.There was patient contact, but there was no reported harm to the patient.Additional information was requested.

Manufacturer Narrative

The device and the lens were returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.The nozzle was removed and cleaned for further evaluation.The nozzle has internal scratches.Top coat dye stain testing was conducted with acceptable results.The lens was returned adhered to the outside of the device with viscoelastic.The lens was cleaned with lphse to remove from the device.One optic haptic junction is split in two places.Scratches are observed from the edge toward the center of the optic on the posterior surface.The scratches may indicate a plunger underride.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause for the reported lens came out sideways could not be determined.The nozzle tip has internal scratches.The lens has scratches and haptic damage that may indicate a plunger underride occurred.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received from the facility indicated that the lens was not implanted and the event was caused by handling/user error.

• 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
• MDR Report Key: 8194897
• MDR Text Key: 131376249
• Report Number: 1119421-2018-01788
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12561285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1