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

Model Number AU00T0

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Eye Injury (1845)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

A sample product was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.Additional information was requested.(b)(4).

Event Description

A surgeon reported that when a preloaded intraocular lens (iol) was injected and unfolded in the eye, he used the end of the plunger rod to seat the lens and then pulled the plunger rod/injector out of the eye.As he was doing so he said ¿he nicked the capsule with the plunger rod and it tore the capsule.¿ the lens was stable in the bag and the tear did not extend.The eye was closed and the surgery ended without any further incident.The surgeon examined the plunger tip and thought there was a design flaw or that the mold used in manufacturing had left an uneven or sharp edge on the side of the plunger rod.Additional information was requested.

Manufacturer Narrative

The device was returned wrapped in a blue glove and was loose in the carton.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Inadequate viscoelastic is observed in the device.The plunger has been retracted into the nozzle tip.There was no damage observed.The plunger was removed from the device and assessed.The reported 'burr' was not observed.No problem was observed with the plunger or device.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified product was used.There was no problem or damage found with the plunger.The plunger was retracted into the tip upon return.The plunger was removed and inspected.The reported burr was not observed on the plunger.The root cause of the event may be related to customer handling.Information was provided that the doctor used the end of the plunger rod to seat the lens and then pulled the plunger rod/injector out of the eye.As the doctor was doing so the doctor said they "nicked the capsule with the plunger rod and it tore the capsule.¿ additional information was provided that the tear did not extend and lens was stable.(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: 7642986
• MDR Text Key: 112501172
• Report Number: 1119421-2018-00824
• Device Sequence Number: 1
• Product Code: KYB
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12562873
• Other Device ID Number: 00380652394857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• 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