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

Catalog Number 8065751763

Device Problems Inability to Irrigate (1337); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

A product sample has been received by the manufacturer and it is awaiting evaluation.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 certified instrument technician reported the irrigation and aspiration (i/a) just stopped during a cataract procedure.The surgeon depressed the footpedal and "nothing happens".Replacing the i/a tip did not resolved the issue however replacing the cassette tubing did.The procedure was completed after replacing the cassette with no patient harm.No additional information is expected.

Manufacturer Narrative

This is the first complaint reported for this finished goods lot and the first reported for this issue.A review of the device history record indicates the order was built to specification.A facility staff member reported that they were having issues during the irrigation and aspiration (i & a) process.A used cassette in a tray was returned and was visually inspected.No obvious defects were observed.The sample was functionally tested using a console.The sample could prime, tune, be recognized by the console and the service data was retrieved successfully.The sample primed and tuned successfully and the service data could be retrieved.No leaks or occlusions were observed.The returned sample functioned within specification.The root cause of the customer's complaint could not be established; as the returned sample met specifications.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as the returned product met specifications.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.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.(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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7607049
• MDR Text Key: 111853420
• Report Number: 2028159-2018-01250
• 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,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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: 380657517633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2013
• 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