MAUDE Adverse Event Report: ALCON LABORATORIES, INC. PERFLUORON; FLUID, INTRAOCULAR

Catalog Number 8065900113

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

No sample or lot number information has been received by manufacturing for evaluation.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 doctor reported that ophthalmic perfluoro-n-octane liquid was used during vitrectomy surgery and was intentionally left inside of the patient's eye upon completion of the procedure.There was unspecified patient harm reported.Additional information has been requested.Additional information received clarified that there is no patient harm specified at this time and no treatment has been provided to the patient however, the retained perfluoro-n-octane liquid has not yet been removed from the patient's eye.

• Brand Name: PERFLUORON
• Type of Device: FLUID, INTRAOCULAR
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6791229
• MDR Text Key: 82771240
• Report Number: 1610287-2017-00058
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P950018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065900113
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• 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