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

Catalog Number 8065900113

Device Problem Insufficient Information (3190)

Patient Problem Retinal Detachment (2047)

Event Date 04/01/2014

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 literature report indicated that while removing perfluorocarbon (pcfl) during the repair of a retinal detachment surgery, the patient experienced a macular hole.Pcfl moved into the subretinal retinal space of the macular hole.The patient had an additional procedure to repair the macular hole.

Manufacturer Narrative

No sample or lot code was returned by this customer; therefore, lot specific evaluation cannot be completed, at this time.The suspected product is contraindicated for long-term use in the eye or as a vitreous replacement.The suspected product 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.Root cause could not be determined, however potential root causes include: ¿ product nonconformance; this is unlikely based on the compounding and filling procedures and controls that are in place.¿ events outside of manufacturer (e.G.Product use, storage conditions, etc.); however, this cannot be confirmed.The manufacturer internal reference number is: (b)(4).

• 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: 6142214
• MDR Text Key: 61347036
• Report Number: 1610287-2016-00124
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/30/2017
• 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
• Treatment: CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR