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

Model Number AU00T0

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested and received.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during a combination dsaek (descemet's stripping automated endothelial keratoplasty) and intraocular lens (iol) implant procedure, the leading haptic of the lens was outstretched.As the lens was being delivered it had a forceful injection.The haptic tore through the posterior capsule.The lens was removed and an anterior vitrectomy was performed.The patient was left aphakic.An iol implantation procedure will be required.Additional information was requested.

Manufacturer Narrative

The manufacturer internal reference number is (b)(4).

Event Description

In a follow up, the surgeon indicated that the patient was seen in follow up (b)(6) 2017 and was still (b)(6).

Manufacturer Narrative

(b)(4).

Event Description

In a follow up, the surgeon indicated that the patient was seen in follow up (b)(6) 2016 and was still aphakic.

• 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: 6123558
• MDR Text Key: 60746540
• Report Number: 1119421-2016-01635
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.240
• Device Lot Number: 12452407
• Other Device ID Number: 380652358354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/06/2017; 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2016
• 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: PROVISC
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR