MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number 8065751512

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2016

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.(b)(4).

Event Description

A surgeon reported that during a procedure the irrigation/aspiration tip was getting hung up on the incision.This has occurred on two patients.Sutures were not required.There was no harm to the patient.This report is for the second patient from this facility.

Manufacturer Narrative

No sample has been returned for evaluation for the report of hung up on incision; 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 manufacturer internal reference number is (b)(4).

• Brand Name: DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS
• Type of Device: DEVICE, IRRIGATION, OCULAR SURGERY
• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6014382
• MDR Text Key: 57402384
• Report Number: 2523835-2016-00767
• 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
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751512
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• 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
• Patient Age: 62 YR