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

Catalog Number 8065751763

Device Problem Air Leak (1008)

Patient Problem Capsular Bag Tear (2639)

Event Date 11/01/2016

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

A surgeon reported that bubbles from the probe obstructed his view and the patient experienced a postcapsular tear on the right eye (od) requiring an anterior vitrectomy to be performed.The event occurred during a bimanual cataract surgery with cortex extraction.The intraocular lens (iol) was implanted in sulcus.Additional information has been requested but none received to date.

Manufacturer Narrative

No probe sample was returned for evaluation for the report of the air bubbles introduced into the anterior chamber; therefore, the condition of the product could not be verified.A video of a small time frame of the surgery was returned and is attached to the complaint file.The video was reviewed and it does show bubbles exiting the port of the probe.No lot number was identified with this complaint; therefore, a lot history review could not be conducted.The video provided with the complaint does confirm the generation of bubbles out of the probe port.The reason for the air leakage from the probe cannot be determined from this evaluation.Air leakage can exit the probe if the aspiration is disengaged for whatever reason while the cutter is active.(b)(4).

• Brand Name: CENTURION 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: 6125855
• MDR Text Key: 60845880
• Report Number: 2028159-2016-05365
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• 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
• Report Date: 01/30/2017

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 Catalogue Number: 8065751763
• Other Device ID Number: 2.04 BLD_0071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED PROBE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR