MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number JAPAN

Device Problems Unstable (1667); Aspiration Issue (2883)

Patient Problem Capsular Bag Tear (2639)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

An ophthalmic surgeon reported that an aspiration failure occurred and the anterior chamber became unstable during a cataract procedure.The posterior capsule ruptured and a vitrectomy procedure was performed in order to retrieve the nucleus that had fallen to the back of the eye.The procedure was completed without product exchange.It was indicated that the product was used once prior to this procedure.Additional information was requested; however, none has been received to date.

Manufacturer Narrative

There have been no additional complaints reported against the finish goods lot and the device history record showed that the product was released per specifications.The customer returned three unused samples; however, these samples do not seem to be the actual samples for this complaint.The three samples were visually and functionally tested and met specifications, no aspiration issues occurred during testing.The root cause of the customer's complaint could not be established as the three unused samples met specifications.(b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5939381
• MDR Text Key: 54314391
• Report Number: 2028159-2016-04078
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

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 Model Number: JAPAN
• Device Catalogue Number: 8065751143
• Other Device ID Number: 2.06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INTREPID PLUS CASSETTE PACK
• Patient Outcome(s): Other; Required Intervention