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

Model Number P-50 PL

Device Problem Occlusion Within Device (1423)

Patient Problems Eye Injury (1845); Intraocular Pressure Increased (1937)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation.The customer suspected that the shunt was clogged; trabeculectomy was performed due to intraocular pressure (iop) increased.It was reported that the shunt remained in the patient's eye.No sample was returned, therefore, the condition of the product could not be verified and visual inspection cannot be performed.The device history record (dhr) for the batch was reviewed.No abnormalities were found during the dhr review and the product was released according to approved release criteria.Since the lot was manufactured, there were 7 other complaints for the lot, 5 of them due to iris touch, 2 of them due to clogged shunt / filtration failure.Because a sample was not returned, the root cause cannot be determined.Additional information has been requested.(b)(4).

Event Description

A customer reported following a glaucoma filtration device implant procedure, a patient experienced a bleb failure and their intraocular pressure (iop) increase.The customer believes the device had become occluded.Suture lysis was performed.The device remains implanted.Additional information was requested.

• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6615013
• MDR Text Key: 76774090
• Report Number: 3003701944-2017-00105
• 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
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2015
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: 122709
• Other Device ID Number: 00380650705013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2012
• 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: MITOMYCIN C CONCENTRATION 0.04%
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 85 YR