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

Model Number AU00T0

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative returned an intraocular lens (iol) as faulty.It is unknown if the case concerns a patient.No further information is expected as no permission to follow up was received.

Manufacturer Narrative

Evaluation summary: the device with the lens was returned in the unopened blister tray inside the opened carton.The internal packaging components were also returned inside the carton.No damage is observed to the product inside the unopened blister tray.The lens stop and plunger lock are in place.The plunger is oriented correctly.The product is placed correctly and securely inside the unopened blister tray.The lens is visible inside the loading area.The lens is positioned correctly.There is no damage observed to the blister tray.The blister seals are complete, intact and undamaged.There is no damage observed to the product cardboard carton.All product and batch history records are quality reviewed prior to product release.There is no problem observed to the returned sample.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: 9774390
• MDR Text Key: 184731681
• Report Number: 1119421-2020-00346
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

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: 01/31/2021
• Device Model Number: AU00T0
• Device Lot Number: 12596842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1