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

Model Number AU00T0

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, they had opened the lens to place it and there was a point in the center of the lens for which it could not be used.Additional information was requested.

Manufacturer Narrative

Evaluation summary: the device with the lens was returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted.The lens appears to have been placed into the loading area for return.Viscoelastic and what appears to be blood are dried on the lens.The lens has a deep gouge on the center of the posterior surface.The lens is also cut from the edge to the center which is similar to removal damage.The root cause for the reported issue cannot be determined.The description states "when opening the lens to place" a mark was observed.This is a preloaded device.It does not require the lens to be handled.The device and the lens were returned with clear signs of use.The gouge on the optic may have occurred due to a plunger underride.This cannot be verified due to the condition of the returned lens and device.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: 9105300
• MDR Text Key: 165643780
• Report Number: 1119421-2019-01548
• 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: 12/06/2019

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: 12501609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1