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

Model Number AU00T0

Device Problems Output above Specifications (1432); Firing Problem (4011)

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

Event Date 01/09/2019

Event Type  malfunction  

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 during an intraocular lens (iol) implant procedure, the lens shot out of the injector toward the end of the injection.There was no capsular rupture, but the surgeon removed the lens and implanted a back up lens into the sulcus as a precaution.The surgeon thinks that the event was influenced by the lens being a "high" power.The surgeon indicated that the patient is in the healing process.

• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8286700
• MDR Text Key: 134449933
• Report Number: 1119421-2019-00112
• 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: Physician
• Type of Report: Initial
• Report Date: 01/29/2019

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: 12573958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• 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