MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON DISPOSABLE ANTERIOR VITRECTOMY COAXIAL IRRIGATION SLEEVE; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number 8065750352

Device Problems Collapse (1099); Device Slipped (1584)

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

Event Date 05/11/2016

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.

Event Description

A customer reported that the sleeve slid off the irrigation and aspiration tip during an eye procedure when sweeping the anterior capsule causing the anterior chamber to collapse.There was no patient harm associated with this event.A product sample was requested for evaluation.

Manufacturer Narrative

As the customer did not retain the finished goods lot number; a device history record review and lot history could not be reviewed.The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted.It is important to remind the customer to return all products associated with the event for a full evaluation.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is not possible to isolate the root cause.(b)(4).

• Brand Name: DISPOSABLE ANTERIOR VITRECTOMY COAXIAL IRRIGATION SLEEVE
• Type of Device: DEVICE, IRRIGATION, OCULAR SURGERY
• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5695628
• MDR Text Key: 47624651
• Report Number: 1644019-2016-00867
• Device Sequence Number: 1
• Product Code: KYG
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750352
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• 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