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

Model Number AU00T0

Device Problem Contamination (1120)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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 one day following an intraocular lens (iol) implant procedure, a thread like foreign material (about 1.2 millimeters) was adhered to the iol.The foreign material is planned to be removed at a later date.No reported patient harm.Additional information has been requested.

Event Description

Additional information has been requested, stating the re-operation to remove the foreign material was completed on (b)(6)2021.After that, there is no problem to the visual acuity, and thus, the surgeon decided, that iol explant was not needed.With her own route, the surgeon is analyzing the components of foreign material.It is unknown, if the analysis result will be provided to the company.

Manufacturer Narrative

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: 11385182
• MDR Text Key: 238400976
• Report Number: 1119421-2021-00440
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2023
• Device Model Number: AU00T0
• Device Lot Number: 15065779
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1