MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER EDGEPLUS TROCAR/CANNULA SET; CANNULA, TROCAR, OPHTHALMIC

Catalog Number 8065751447

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

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 has been received by the manufacturer and it is awaiting evaluation.(b)(4).

Event Description

A customer reported that during the removal of the trocar from the patient's eye, the orange part (located outside the sclera) broke off.There was no harm to the patient.No additional information is expected.

Manufacturer Narrative

Two opened trocar hub/cannula assemblies were received in an opened pouch for the report of broken trocar.The returned samples were visually inspected.One sample was found conforming and one sample was found non-conforming with the hub missing and adhesive present on the cannula.The conforming sample was then functionally tested for bond strength and was found non-conforming.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.During assembly of the trocar product adhesive is dispensed at the cannula hub interface.The evaluation of the returned samples identified adhesive on one of the cannula, however functional testing of the second assembly found the assembly to not have adequate adhesive application.The root cause of this complaint is inadequate adhesive application.Investigation photos of the returned samples has been reviewed with the applicable production personnel to raise awareness of this issue.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: EDGEPLUS TROCAR/CANNULA SET
• Type of Device: CANNULA, TROCAR, OPHTHALMIC
• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6969575
• MDR Text Key: 90404773
• Report Number: 2028159-2017-04125
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 8065751447
• Device Lot Number: 16013986X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2016
• 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