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

Model Number P-50 PL

Device Problems Occlusion Within Device (1423); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.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 complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Additional information has been requested.(b)(4).

Event Description

A doctor reported that during a glaucoma filtration device (gfd) implant procedure, there was no flow of aqueous humor from the gfd.The gfd was clogged.The gfd was removed and the procedure was completed another device.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: only shunt was received for investigation.During inner illumination test, the shunt lumen was found open.Therefore, the customer complaint could not be confirmed.There was 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.Therefore, there is no indication for manufacturing related factors that could cause the reported event.During production, 100% final inspection is being performed on the entire batch, including visual inspection and inner illumination.If a blockage would be noticed, the product would have been rejected immediately.The root cause is inconclusive ¿ product met specifications, since the blockage was not confirmed and there is no indication for an inherent defect that might have caused the event.The manufacturer internal reference number is: (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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6382248
• MDR Text Key: 69489126
• Report Number: 3003701944-2017-00040
• 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: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• 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
• Other Device ID Number: 00380650705013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• 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
• Patient Outcome(s): Other