MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number ACU0T0

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

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 is one other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during implantation of an intraocular lens (iol) the end of plunger had an extra plastic piece not allowing lens getting out easily.Surgeon used an hook to hold the lens in the eye otherwise the lens could stuck in the plunger.There was patient contact but there was no patient harm.Additional information was requested.

Manufacturer Narrative

The device was returned loose.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has been retracted to just behind the end of the wound guard.No extra material was observed on the plunger.The plunger was removed for further evaluation.The plunger was cleaned to removed the ovd.No extra plastic was observed.The plunger is designed with a groove on the top left.The plunger is also designed with an upper an lower flange.No damage or abnormalities were observed with the plunger tip.The plunger was able to be fully advanced outside of the nozzle tip with no issue observed.The nozzle tip was damaged.The tip was cleaned to assess the damage.The tip has heavy stress, is bent inward and is cracked on the top right.It is unknown if this damage occurred during advancement, was caused by manipulation to release the iol or if it may have occurred during return shipment as the device was unsecured.The lens was not returned.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.No problems were found with the returned plunger.The plunger is designed with a groove on the top left.The plunger is also designed with an upper an lower flange.No damage or abnormalities were observed with the plunger tip.The plunger was able to be fully advanced outside of the nozzle tip with no issue observed.Plunger manufacturing is a validated operation, with specifications that are maintained and documented.The plunger position in relation to the lens during advancement cannot be determined.Damage was observed to the nozzle tip.It cannot be determined when this damage occurred.It is unknown if this damage occurred during advancement, was caused by manipulation to release the iol or if it may have occurred during return shipment as the device was unsecured.Nozzle tip damage is atypical.If the damage occurred during advancement, it may indicate the lens/plunger were not in a proper position per the ifu.The ifu instructs: "after the lens has been advanced to the ¿fill-to¿ 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.No part of the lens should exit the nozzle prior to insertion through the incision." diagrams are provided that show acceptable haptic positions with additional instructions.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken 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 ASPHERIC UV ABSORBING IOLWITH 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: 12094859
• MDR Text Key: 259265406
• Report Number: 1119421-2021-01290
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652395328
• UDI-Public: 00380652395328
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

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: 05/14/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15071610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC