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

Model Number AU00T0

Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided by the reporter for further investigation.There have been no manufacturing changes with the company device.No determination can be made without physical evaluation of the sample.The reporter has indicated they do not want to provide any further information.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during a cataract extraction with an intraocular lens (iol) implant procedure, the intraocular lens tore minimally when injected into the patient's eye.It seemed to doctor that it was slightly different in appearance and a little harder to inject the intraocular lens.Something was strange and the distal haptic did not appear to position itself in the usual way.Additional information was requested, but further no information was available.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• 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: 15622828
• MDR Text Key: 303268398
• Report Number: 1119421-2022-02206
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 10/18/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1