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

Model Number AU00T0

Device Problem Unintended Ejection (1234)

Patient Problems Capsular Bag Tear (2639); Zonular Dehiscence (2698); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2022

Event Type  malfunction  

Event Description

A nurse reported at the time of admission suddenly lens slipped far too fast, the entire lens capsule was loose and the lens had to be cut out and the patient was left in the current condition.Additional information was requested and was received.

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported at the time of admission suddenly lens slipped far too fast, the entire lens capsule was loose and the lens had to be cut out and the patient was left in the current condition.Additional information was requested and was received.

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

On initial mdr the fda patient event code of 4582 was an error.It should have been 2639, 4581, 2698 on the original mdr.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was requested and received that during implantation of the iol into the bag, the preloaded iol slides with some resistance through the cartridge and the suddenly accelerates and is injected with high velocity into the capsular bag, causing a posterior capsular break and a superior zonolysis 180 degrees.There was also damage to the corneal endothelium, although unclear whether through the implantation or the explantation of the iol.

• 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: 13577914
• MDR Text Key: 285946205
• Report Number: 1119421-2022-00336
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394819
• UDI-Public: 00380652394819
• 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
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• 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: 15273123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• 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
• Patient Age: 85 YR
• Patient Sex: Male