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

Catalog Number 8065751763

Device Problems Leak/Splash (1354); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2015

Event Type  malfunction  

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 doctor reported that the cassette leaked from the tubing connection and caused the anterior chamber to become unstable during the cataract procedure.The surgery was completed without replacing the product.There was no patient harm reported.Additional information and product sample have been requested.

Manufacturer Narrative

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

Event Description

The customer clarified that the event occurred with two patients.

Manufacturer Narrative

Additional information: this is one of two complaints reported for this finished goods lot; however, this is the first for this issue for this lot.Review of the device history record indicates the order was built to specification.Two wet and used cassettes were visually inspected.The drain bags were detached from the covers of the cassettes due to saturation.Both irrigation and aspiration luers were intact.Flare shape was observed in the blue socket fittings at the aspiration tubing insertion end.The samples could be recognized and the service data could be retrieved from the console.The samples primed and tuned successfully and reached maximum vacuum.The drain bag tapes were adhered on the cassette properly.The irrigation and aspiration flow rates were within specification.No drop presented from the irrigation luers.No damage was found on the fittings.No leakage was detected from the tubing insertion to the fittings and to the cassettes.The samples functioned per specification.The root cause of the customer's complaint could not be established; the returned sample met specifications.(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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5307035
• MDR Text Key: 34469536
• Report Number: 2028159-2015-10119
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2016

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 Catalogue Number: 8065751763
• Other Device ID Number: 2.03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2016; 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2014
• 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
• Patient Outcome(s): Other