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

Catalog Number ASKU

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

No data regarding product identity were indicated for the event; therefore, the device history record (dhr) could not be reviewed.No sample was returned; therefore, the condition of the product could not be verified.Because a sample was not returned and no lot number was indicated for this complaint, the root cause cannot be determined.The directions for use (dfu) for this product states: pfo must be completely removed at the conclusion of the procedure by aspiration through either a 23 gauge or flute needle during the air-fluid exchange, or by direct exchange with an appropriate long-term vitreous substitute.Failure to remove may result in visual abnormalities and secondary surgical intervention.(b)(4).

Event Description

In a literature article information was presented with regard to a retrospective study of a cluster of six cases of retained intraocular perfluoron (pfo) that occurred after pars plana vitrectomy (ppv) for retinal detachment repair.Pfo was noted in the anterior chamber (ac) and/or vitreous and removed with ac paracentesis, ac wash-out, and/or ppv.These cases were noted shortly after the facility transitioned from non-valved trocar cannulas to valved trocar cannulas between may 16, 2012 through january 7, 2013.This is the fifth of six reports.Reference: oellers p, schneider e, fekrat s, mahmoud t, mruthyunjaya p, hahn p.Retained intraocular perfluoro-n-octane after valved cannula pars plana vitrectomy for retinal detachment.Ophthalmic surg lasers imaging retina.2015; 46: 451-456.

• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5903081
• MDR Text Key: 52948827
• Report Number: 1610287-2016-00094
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950018
• 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
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR