MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC; CANNULA, OPHTHALMIC

Catalog Number 8065420020

Device Problem Detachment Of Device Component (1104)

Patient Problem Corneal Abrasion (1789)

Event Type  malfunction  

Manufacturer Narrative

No sample has been returned for evaluation for the report of cannula blew off; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.A sample was not returned and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.There have been no changes to the design of the reported product.An acceptance quality limit (aql) sampling is performed to ensure that the product meets release acceptance criteria.The inspection includes evaluation for luer taper.Any non-conforming product found is removed from the lot and scrapped.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported a cannula shot off the during preparation and caused a corneal abrasion.It was reported no harm to the patient.Additional information was requested, however, the reporter indicated he was unable to provide additional information.This is one of two reports for this surgeon.

• Brand Name: ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
• Type of Device: CANNULA, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7325225
• MDR Text Key: 102077344
• Report Number: 2523835-2018-00115
• Device Sequence Number: 1
• Product Code: HMX
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065420020
• Device Lot Number: ASKU
• Other Device ID Number: 380654200200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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