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

Catalog Number 8065751763

Device Problems Air Leak (1008); Suction Problem (2170)

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

Event Type  malfunction  

Manufacturer Narrative

The lot specific to this event is not known; therefore, lot history and device history record (dhr) reviews are not possible.The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted.The root cause of the customer's complaint could not be established as a sample has not been received; however, complaints of a similar nature referencing aspiration/suction issues have been received and the most likely root cause is an error during the supplier¿s manufacturing process of the blue aspiration luer on the centurion manifold.It has been found that the blue luer on the manifold is not creating a complete seal resulting in air flow.An action has been opened to determine root cause and implement appropriate corrective actions for complaints of this nature.Quality assurance will continue to monitor customer complaints and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

Event Description

An operating room supervisor reported loss of suction and bubbles in the tubing and the fluid collection bags during an unspecified number of cataract procedures.The procedures were completed without patient harm.Additional information and product samples have been requested.

Manufacturer Narrative

The lot specific to this event is not known; therefore, lot history and device history record (dhr) reviews are not possible.The customer did not retain a sample for this complaint report; therefore, visual inspection and functional testing could not be conducted.Though the definitive root cause of this customer's complaint cannot be determined, as a sample was not returned for investigation, complaints of a similar nature referencing aspiration/suction issues have been received and the root cause of the customer's complaint is an error during the supplier's manufacturing process of the blue aspiration luer.It has been determined that some of the blue luers from one of the six supplier cavities (cavity 3) from one supplier lot can allow air to enter the aspiration line and reduce the ability of the sample to reach maximum vacuum.An action has been opened to determine root cause and implement appropriate corrective actions for complaints of this nature.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.(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: 5471741
• MDR Text Key: 39672008
• Report Number: 2028159-2016-00936
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

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: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• 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