MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number ACU0T0

Device Problem Defective Device (2588)

Patient Problem Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

The product was not returned.All product and batch history records are quality reviewed prior to product release.Viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the reported event/issue.It is unknown if a qualified viscoelastic was used.There are no other complaints in this lot.Investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that following an intraocular lens (iol) implant procedure, the patient experienced glare symptoms and the iol had the apparent crease.The iol was exchanged in a secondary procedure approximately 10 months following the initial procedure.No further information is expected.

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH 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 ; 8175514979
• MDR Report Key: 12342809
• MDR Text Key: 267280630
• Report Number: 1119421-2021-01595
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652395267
• UDI-Public: 00380652395267
• 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
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: ACU0T0
• Device Lot Number: 12675987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention