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

Model Number AU00T0

Device Problems Defective Device (2588); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

A non-health care professional reported during the intraocular lens implantation a defect was noticed on the lens optic.Additional information has been requested and received stating the patient was not hospitalized for the event and the surgery was completed on the same day with a back up lens.

Manufacturer Narrative

Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

An (pre-loaded lens injector) was used, instead of previously reported handpiece.

• 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: 13751348
• MDR Text Key: 287191708
• Report Number: 1119421-2022-00458
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394796
• UDI-Public: 00380652394796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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: 15279460
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/13/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTREPID AUTOSERT IOL HANDPIECE.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 79 YR
• Patient Sex: Male