MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752918

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Date 08/16/2017

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.A product sample was received at the manufacturing site and it is awaiting evaluation.(b)(4).

Event Description

A customer reported that a piece of sleeve broke off and fell into the eye during an eye surgery with suspicion that it is still in the eye.No patient harm reported.A product sample and additional information has been requested for this report.No additional information has been received at this time.

Manufacturer Narrative

A device history review (dhr) indicates that the order was built to specifications.The returned sample was visually inspected and the issue was confirmed, a hole was found in the shaft of the infusion sleeve.The damage appears to have what resembles phaco tip piercing damage at the center section of the shaft.The root cause of the customer¿s complaint is most likely related to user handling during set-up.The marks on the sleeve have what resembles phaco tip damage; when the sleeve was installed over the phaco tip and the tip pierces the sleeve.(b)(4).

Manufacturer Narrative

Date received by mfg) for smdr 1 (mfg report num: 1644019-2017-00717) is 11/14/2017.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6854705
• MDR Text Key: 85911293
• Report Number: 1644019-2017-00717
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 8065752918
• Device Lot Number: 2027261H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other