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

Model Number AU00T0

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure the lens shot out of the applicator and went through the posterior capsular wall.A vitrectomy was performed.Additional information was requested.

Manufacturer Narrative

The device and the lens were returned separated.The device was evaluated.The plunger is oriented correctly.There appears to be inadequate viscoelastic observed in the device.The plunger has been retracted to mid-nozzle.The nozzle tip has a large aneurysm on the bottom and a small tear on the side.This damage would indicate the lens/plunger were not in a proper position for advancement.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The lens was loose in the plastic bag.Viscoelastic is observed on the lens.One haptic is broken-not returned.It is unknown if the haptic damage occurred during the delivery or the lens removal.The lens has been cut in half typical of a removal.One portion has a chipped area on the edge with material removed.A qualified viscoelastic was indicated.The root cause for the reported event could not be determined.The device tip exhibited damage (large aneurysm, and a small split) that would indicate the lens/plunger were not in acceptable positions for advancement.The dfu instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.A broken haptic was also observed.Top coat dye stain testing was conducted with acceptable results.In addition, there did not appear to be adequate viscoelastic in the device.The dfu instructs: fill the device until viscoelastic can be observed flowing to the line on the nozzle tip.This will require approximately 0.2 ml of viscoelastic.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device.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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8062319
• MDR Text Key: 126891074
• Report Number: 1119421-2018-01596
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12569399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR