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

Model Number AU00T0

Device Problem Crack (1135)

Patient Problems Intraocular Pressure Increased (1937); Capsular Bag Tear (2639)

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that following insertion of an intraocular lens (iol) during an implantation procedure, the doctor noticed that the iol had a crack on the optic zone close to the connection of the optic and the haptic.A small rupture of the posterior capsule occurred.The surgeon removed the vitreous from the anterior chamber and tamponade the rupture with an ovd.The iol remains in the eye.The surgeon did not replace the iol based on the location of the crack and no negative consequences for the patient.The iol is well positioned in the capsule.Additional information indicated that the patient had elevated intraocular pressure due to the ovd tamponade.

Manufacturer Narrative

Correction: on initial report, the fda patient code 1937 and patient age units were missed to report.Corrected information provided in a.2, and h.6.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: 11824929
• MDR Text Key: 250622181
• Report Number: 1119421-2021-01034
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394802
• UDI-Public: 00380652394802
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Model Number: AU00T0
• Device Lot Number: 15031652
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention