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 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

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 facility representative reported that during a cataract surgery with an intraocular lens (iol) implantation, the lens was found to be damaged.The iol was replaced in the same procedure with no reported harm to the patient.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The root cause may be related to a failure to follow the directions for use.A non-qualified viscoelastic was used in the device.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was provided indicating that the event occurred during injection.The device did come in contact with the patient when the iol was inserted into the anterior chamber and they had to remove the iol immediately because the iol had a broken haptic.There was no patient harm/symptoms.The procedure was completed with another iol.The patient is doing well/recovered with the other 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
• MDR Report Key: 11646644
• MDR Text Key: 244855464
• Report Number: 1119421-2021-00788
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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 Expiration Date: 07/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12738782
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/10/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: METYLCELLULOSE
• Patient Age: 58 YR