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

Catalog Number 80659001AB

Device Problem Insufficient Information (3190)

Patient Problems Optical Nerve Damage (1986); Therapeutic Effects, Unexpected (2099); Visual Impairment (2138); Fibrosis (3167)

Event Date 09/08/2015

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21cfr 803.56 when additional reportable information becomes available.Additional information has been requested but not received to date.(b)(4).

Event Description

A healthcare professional reported that ophthalmic perfluorocarbon liquid was used in a posterior vitrectomy surgery after which the patient experienced macular fibrosis, atrophy of the optic nerve and difficult light perception in the left eye (os).The surgery was without complications but patient had an unexpected evolution.There were no chances of visual improvement in the eye.Additional information has been requested but not received to date.

Event Description

Additional information was provided by the ophthalmology head service.The patient was not hospitalized.No medical intervention was required to treat the event.Accordig to the surgeon's opinion, it is unknown if the device caused or contributed to the event.

• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5438030
• MDR Text Key: 38227652
• Report Number: 1610287-2016-00007
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80659001AB
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• 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
• Treatment: ENDOLASER
• Patient Outcome(s): Disability
• Patient Age: 52 YR