MAUDE Adverse Event Report: OPTONOL LTD. EX-PRESS GLAUCOMA FILTRATION DEVICE; IMPLANT, EYE VALVE

Model Number P-50 PL

Device Problem No Flow (2991)

Patient Problem Intraocular Pressure Increased (1937)

Event Date 10/28/2013

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.No data regarding product identity was received i.E.No lot or serial number 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 or serial number were indicated for this complaint, the root cause cannot be determined.Additional information was requested and received.Zip code is not indicated at this time.(b)(4).

Event Description

A surgeon reported that approximately 7 months after a glaucoma filtering shunt was implanted, the patient had increased intraocular pressure (iop).The scleral flap was opened and it was confirmed there was no flow of fluid through the shunt, was thought to be associated with scarring.The shunt was removed and a trabeculectomy was performed.Early in the postoperative management it was indicated that two sutures were lysed and a needling procedure had taken place.The patient was also noted to have been hospitalized for a prolonged period during the treatment time frame.The patient was indicated as recovering three weeks after the intervention.

Manufacturer Narrative

(b)(4).

• Brand Name: EX-PRESS GLAUCOMA FILTRATION DEVICE
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): OPTONOL LTD.; kiryat hatikshoret; communication center; neve-ilan 90850 ; IS 90850
• Manufacturer (Section G): OPTONOL LTD.; kiryat hatikshoret; communication center; neve-ilan 90850 ; IS 90850
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5343929
• MDR Text Key: 35058186
• Report Number: 3003701944-2016-00004
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 01/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 66 YR