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

Model Number AU00T0

Device Problems Cut In Material (2454); Pressure Problem (3012)

Patient Problem No Code Available (3191)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

A sample device was not received for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.An approved ovd was indicated as being used in the device.Root cause has not been identified.There are no other complaints reported in the lot.Additional information has been requested.(b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, he could sense that pressure was building as he was progressing the lens through the injector.The pressure released and the lens jolted into the eye.A radial tear was noted on the anterior capsular rim, as well as, a nick to the lens optic.The lens was stabilized and implanted at that time.The surgeon commented that prior to implanting the lens he thought it looked contorted.During the one day postoperative exam the surgeon indicated that the patient's vision was good and the events did not compromise the outcome.Additional information was requested.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6342303
• MDR Text Key: 67805491
• Report Number: 1119421-2017-00245
• 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
• Report Date: 02/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.220
• Device Lot Number: 12490190
• Other Device ID Number: 380652358316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2016
• 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
• Treatment: VISCOAT
• Patient Outcome(s): Other