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

Model Number AU00T0

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An ophthalmologist reported that during an intraocular lens (iol) implant procedure, the leading haptic emerged from the preloaded device misdirected and caused the lens to flip inside the capsular bag and unfolded upside down.The surgeon removed the iol which caused significant wound damage.Several sutures were required to complete the procedure.Additional information has been requested.

Event Description

In a follow up, the doctor reported one suture was removed from the patient's eye.The patient's vision and cornea are ok and he will reevaluate in three weeks.

Manufacturer Narrative

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: 8512439
• MDR Text Key: 141896981
• Report Number: 1119421-2019-00474
• Device Sequence Number: 0
• Product Code: KYB
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12580858
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/13/2019
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR