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 Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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.The product was released according to manufacturer's release criteria.Because a sample was not returned, the root cause cannot be determined.The root cause will be reassessed upon completing the investigation.Additional information has been requested.(b)(4).

Event Description

A nurse reported occlusion of a device during a glaucoma filtering device implant procedure.The device was removed and replaced with during the same procedure.There was no patient harm.Additional information has been requested.

Manufacturer Narrative

Product evaluation: the customer reported that 'the device felt occluded, it was removed and replaced during same procedure'.Sample was returned for investigation, including the shunt and the eds (separately).Some light blockages were seen in initial inner illumination.Therefore, the reported complaint was confirmed.After cleaning the shunt, openings on both sides of the restriction unit were seen with no interruptions; therefore, there is no indication for manufacturing related factors that could cause the blockage.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.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.Due to all of the above, one may conclude that the blockage was formed after the product left the manufacturing plant.The root cause is inconclusive ¿ no root cause identified, as the blockage could have been caused by many different reasons during and after the clinical procedure.Since openings were seen on both sides of the restriction unit, 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: 6336095
• MDR Text Key: 67934873
• Report Number: 3003701944-2017-00026
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: P-50 PL
• Device Catalogue Number: 40753
• Device Lot Number: 072704
• Other Device ID Number: 00380650704931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Date Device Manufactured: 05/04/2016
• 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