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 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.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 facility representative reported that during a cataract surgery with an intraocular lens (iol) implantation, the nozzle was found to be "defective." the iol was implanted with no reported harm to the patient.Additional information has been requested.

Manufacturer Narrative

A company representative visited the surgery facility and observed seven cases with the surgeon.No tip issues occurred.It was stated that no issues were observed since the last reported events.Two possible associated factors were observed: the scrub nurses loaded the ovd through the device tip instead of the port.This is a failure to follow the dfu.The product dfu was reviewed for use as indicated.The dfu instructs: fully insert the viscoelastic cannula, perpendicular to the device, through the viscoelastic port, located in the lens stop portion of the device (a diagram is given).Fill the device until viscoelastic can be observed flowing to the line on the nozzle tip (a diagram is given), then retract the cannula.It was also noted that the scrub nurse manually re-inserted straight leading haptics back into the tip.Due to the fragile nature of the tip, instruments should not be inserted into or pressed against the tip as this may cause damage.The surgeon has indicated the devices will be inspected in the packaged and when opened and any further issues will be reported.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: 11436349
• MDR Text Key: 242417715
• Report Number: 1119421-2021-00507
• 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: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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 Model Number: AU00T0
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1