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

Model Number AU00T0

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

A sample device was not 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.(b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the tip of the plunger came off the injector and was in the eye.The surgeon removed the tip of the iol inserter from the eye & completed the surgery in the usual manner.Additional information was requested.

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6.And h.10.The used device was returned loose in the opened carton.The lens was not returned.The plunger lock and lens stop have been removed.The plunger was oriented correctly.An abundant amount of viscoelastic was observed inside the device and on the exterior of the nozzle tip.The plunger was retracted to mid-nozzle.The plunger appeared undamaged in the device.The nozzle tip of the device was heavily stressed.The stress enlarged into torn damage along the left side of the device.The torn tip of the device was most likely interpreted as the reported complaint.The plunger was removed for further assessment.There was no damage to the plunger.The plunger was reinserted inside the barrel.No plunger anomalies were observed.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause could not be determined for the reported complaint.The initial report description explained that "the tip of the plunger came off the injector and was in the eye." the reported plunger tip damage was not observed.The plunger was removed from the device and evaluated.There were no missing pieces of the plunger tip.However, the device nozzle tip of the device was stressed and torn along the right side.Several follow up attempts were made for clarification.No further information has been provided.The heavily stressed and torn device tip was most likely interpreted as the reported complaint.The plunger was retracted upon return.The plunger position in relation to the lens during advancement cannot be determined.The torn damage to the device tip may suggest that the lens was not in a proper position for advancement.This damage would indicate the lens/plunger were not in an acceptable position for advancement.The instructions for use (ifu) instructs: after the lens has been advanced to the nozzle 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.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.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.There are no other complaints in this lot.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14853159
• MDR Text Key: 294948741
• Report Number: 1119421-2022-01413
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394772
• UDI-Public: 00380652394772
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15287473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VISCOAT