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 08/24/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: a customer reported that there was no drainage and the shunt was explanted.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 release criteria.No sample received when completing the preliminary summary, therefore, the condition of the sample could not be verified.All products pass 100% final inspection prior to approval.If a defect would be noticed, the product would have been rejected and segregated immediately.The root cause cannot be determined as no sample received.The root cause will be reassessed.There have been no other complaints reported in the lot number.Additional information has been requested and received.(b)(4).

Event Description

A healthcare professional reported a glaucoma filtering device that would not drain 3 days following a device implant procedure.On the 7th day the device was removed.Additional information was provided by the physician, who reported that in the first 2-4 days there was a suspicion of no filtration through the shunt.After 5 days with underlying moderate increased intraocular pressure it was decided to revise the surgery area; during that surgery there was absence of filtration through the general shunt's canal.The shunt was removed and a traditional trabeculectomy was preformed at that time.The event has not resolved.

Manufacturer Narrative

Evaluation summary: the product was returned for investigation: the lumen was found to be open.Therefore, the complaint cannot be confirmed.The root cause is inconclusive - no problem found since during inner illumination the lumen was found to be open.The blockage could have been caused by many different reasons during and after the clinical procedure.The reported blockage does not seem to be product related.(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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6964893
• MDR Text Key: 89827423
• Report Number: 3003701944-2017-00160
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 12/01/2017

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: 24053
• Device Lot Number: ASKU
• Other Device ID Number: 00380650704962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 11/23/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 25 G NEEDLE; 8.0 SILK SUTURE; DEXAMETHASONE; DICLOFENAC; INFINITI CAUTERY; VIGAMOX
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 79 YR