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

Model Number AU00T0

Device Problem Device Damaged by Another Device (2915)

Patient Problem Corneal Edema (1791)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A health care professional reported that during an intraocular lens (iol) implant procedure one of the haptics was wrongly folded.There was indication that a patient was involved, as well as, postoperative corneal edema that was noted as improving.Additional information was requested.

Manufacturer Narrative

The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

• 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: 11405712
• MDR Text Key: 234483723
• Report Number: 1119421-2021-00470
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394765
• UDI-Public: 00380652394765
• 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
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: AU00T0
• Device Lot Number: 15071674
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other