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

Model Number AU00T0

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.The 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.(b)(4).

Event Description

A health professional reported that during an intraocular lens (iol) implant surgery, the lens did not come out of the injector properly during the injection portion of the surgery.The surgeon opened another lens and completed the surgery.There was no patient impact.Additional information has been requested.

Manufacturer Narrative

The device with the lens was returned.The plunger lock and lens stop were removed.The plunger is oriented correctly.There is no viscoelastic is observed in the device.The plunger has been advanced to just inside the nozzle entry area and has underrode the lens.The lens is slightly advanced into the nozzle entry area with the majority of the lens still located in the loading area, positioned on top of the plunger.The optic is scraped along the posterior optic surface along the plunger travel path.The trailing haptic is misfolded under the optic and is broken at the gusset and distal area.The trailing haptic is located along the left side of plunger with distal tip oriented toward nozzle tip.The leading haptic is bent toward the optic.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated; however there was no evidence of viscoelastic observed in the device.A plunger underride was observed.Broken haptic damage and scraped optic damage was also observed.The root cause is related to a failure to follow the dfu.There was no viscoelastic observed inside of the device.This would indicate the device was not filled per the dfu.A lens delivery should never be attempted without the addition of a qualified viscoelastic into 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 allowing the plunger to underride the lens.A non-qualified viscoelastic was indicated; however there was no evidence of viscoelastic observed 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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7758719
• MDR Text Key: 116631357
• Report Number: 1119421-2018-01102
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: AU00T0
• Device Lot Number: 12576091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other