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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: only the delivery system device was returned in the opened blister tray inside the opened carton.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The device exterior has what appeared to be dried blood at the wound guard.The plunger was retracted into the loading area.There was no damage observed to the device.The plunger was removed and evaluated.There was no damage or abnormalities observed to the plunger.The plunger was reinserted into the device with no difficulties.All product and batch history records are quality reviewed prior to product release.A qualified viscoelastic was used.The root cause could not be determined for the reported event of "plunger advanced iol while turning right".Only the used, undamaged device was returned.There was no problem found with the device.The device exterior has what appeared to be dried blood at the wound guard.The plunger was retracted upon return.The plunger was removed and evaluated.There was no damage or anomalies observed to the plunger.The plunger was reinserted into the device with no difficulty.The plunger position in relation to the lens during advancement cannot be determined.It cannot be confirmed if the lens was in a proper position for advancement.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported during a cataract with intraocular lens (iol) implant procedure, that after touching an iol, a plunger advanced the iol while turning to the right.The iol was implanted, and the surgery was completed.There was no patient impact reported.

• 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 ; 8175514979
• MDR Report Key: 11752205
• MDR Text Key: 248194067
• Report Number: 1119421-2021-00922
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2021

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: 08/26/2023
• Device Model Number: AU00T0
• Device Lot Number: 15094349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE