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

Model Number AU00T0

Device Problem Ejection Problem (4009)

Patient Problems Corneal Edema (1791); Capsular Bag Tear (2639)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported during a cataract extraction with an intraocular lens implant procedure, the plunger was hard to push and suddenly it come loose and made the iol to get into the eye as a projectile, resulting in an capsular break.The patient was left without any len.

Event Description

Additional information requested and received which states that there was also damage to the corneal endothelium, although unclear whether during implantation or the explantation of the iol.A secondary implantation of an iris fixed iol is planned, possibly also a corneal endothelium transplantation may be needed.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received which states that this file is a duplicate of pr 1934269 and therefore has to be cancelled.

Manufacturer Narrative

This is a duplicate of manufacturer report number 1119421-2022-00336.No additional reports will be filed on this report number.¿ any additional information that is received will be reported on manufacturer report number 1119421-2022-00336.The manufacturer internal reference number is: 2022-06307.

• 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: 13559617
• MDR Text Key: 285821122
• Report Number: 1119421-2022-00313
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 05/11/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15273123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 02/16/2022; 04/13/2022
• Supplement Dates FDA Received: 03/11/2022; 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male