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

Model Number AU00T0

Device Problems Sticking (1597); Torn Material (3024)

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

Event Date 04/23/2018

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 is one other complaint in the lot.Additional information was requested.(b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, one of the haptics stuck to the optic of the lens and the lens was torn.There was patient contact, but no patient harm.Additional information was requested.

Manufacturer Narrative

The device and the lens were returned separately.The plunger lock and the lens stop were removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.A broken haptic is observed.The haptic is on the left side of the plunger in the groove (correct).The distal portion is facing the end of the nozzle.The leading haptic and the optic were returned and were broken in a small bag.Viscoelastic was observed on the lens.A qualified viscoelastic was used.The root cause for the complaint could not be determined.The optic and lead haptic were returned separate and were broken.The broken trailing haptic is present in the device on the correct side of the plunger extended in the plunger groove.The distal portion is facing the end of the nozzle.The plunger was retracted.The plunger position in relation to the broken haptic during advancement cannot be determined.The haptic position may indicate the plunger was not fully advanced.If the plunger is not fully advanced the trailing haptic may not release properly from the device.Additional information was provided.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: 7527523
• MDR Text Key: 108807038
• Report Number: 1119421-2018-00628
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12556421
• Other Device ID Number: 00380652394741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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
• Patient Age: 43 YR