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

Model Number AU00T0

Device Problems Break (1069); Sticking (1597)

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

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and 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.(b)(4).

Event Description

A facility representative reported that an intraocular lens (iol) became stuck in the injector and then broke prior to iol insertion into the eye.There was no patient contact.Additional information was requested.

Manufacturer Narrative

The device and the lens were returned in the carton.The lens was returned inside a sealed pouch.Viscoelastic was dried on the lens.One haptic was broken (not returned).The optic has a large portion broken.Viscoelastic was observed dried in the device.The plunger is oriented correctly.The lens stop and plunger lock were removed.The plunger was retracted to mid-nozzle.The nozzle tip has an aneurysm on the left side and is bent backward on the anterior surface as if in contact with a hard surface.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted.The damage observed at the beveled tip exit of the nozzle has caused a small disruption in the coating material in that area.Top coat dye stain testing results in all the remaining areas were acceptable.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause could not be determined for the reported ¿lens stuck and broke¿.Lens damage was observed.The lens was returned outside of device.The plunger was retracted upon return.The plunger position in relation to the broken haptic and optic during advancement cannot be determined.The nozzle tip was damaged.This is not a typical occurrence and would indicate the lens/plunger were not in an acceptable position for advancement.Excessive force would have been necessary to cause the observed tip damage.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: 7489496
• MDR Text Key: 107573956
• Report Number: 1119421-2018-00527
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12533911
• Other Device ID Number: 00380652358255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2017
• 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