MAUDE Adverse Event Report: ALCON LABORATORIES, INC. SILIKON 1000 OIL; FLUID, INTRAOCULAR

Catalog Number 8065601187

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that following a vitreoretinal procedure, 2-3 days postoperatively, it was found that the ophthalmic liquid and oil remained in the patient's eye.An additional procedure was preformed in order to remove the liquid and gas.Additional information has been requested.This is two of two reports filed for this event.

Manufacturer Narrative

No sample or lot code was provided.All compounding, preprocessing, filling and packaging manufacturing batch records are subjected to 2 independent reviews.Review of the incoming inspection results for the component lot codes are completed prior to disposition.Incoming components are verified to meet key design criteria via dimensional analysis and attribute inspection prior to disposition.The root cause of the complaint condition cannot be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: SILIKON 1000 OIL
• Type of Device: FLUID, INTRAOCULAR
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 8134847
• MDR Text Key: 129384022
• Report Number: 1610287-2018-00050
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• PMA/PMN Number: P950008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065601187
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention