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

Model Number AU00T0

Device Problem Entrapment of Device (1212)

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

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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.(b)(4).

Event Description

A customer reported an intraocular lens (iol) was stuck in a preloaded delivery system and was twisted/damaged.Additional information was requested.

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Additional information provided.The device and the lens were returned separate inside the opened blister tray.The tray was completely wrapped in tape.The plunger lock and lens stop have been removed from the device.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been fully advanced outside of the nozzle tip.No damage was observed to the device or plunger.The iol was adhered to the bottom of the tray in solution.The lens was removed and cleaned using lphse.No damage was observed to the optic or the haptics.A dimensional inspection (plan view) was conducted.The lens was within the specification per the approved template.Product history records were reviewed and the documentation indicated the product met release criteria.Two viscoelastics were indicated, and both are qualified for use in the device.The root cause for the complaint cannot be determined.The sample was not returned in the reported condition.The lens was returned separated from the device.The plunger was fully advanced.No damage or abnormalities were found with the returned device or the lens.A dimensional inspection (plan view) was conducted.The lens was within the specification per the approved template.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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: 7491095
• MDR Text Key: 107604521
• Report Number: 1119421-2018-00537
• 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,Followup,Followup,Followup
• Report Date: 04/29/2019

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: 09/30/2019
• Device Model Number: AU00T0
• Device Lot Number: 12501618
• Other Device ID Number: 00380652358408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 05/02/2018; 05/30/2018; 07/10/2018; 04/04/2019
• Supplement Dates FDA Received: 05/21/2018; 06/20/2018; 07/17/2018; 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC
• Patient Outcome(s): Other