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

Model Number P-50 PL

Device Problems Device Displays Incorrect Message (2591); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

The sample has not been received by the investigator at the time of the preliminary summary completion.The device history record (dhr) was reviewed and no abnormalities were found.The product was released according to release criteria.There is one similar complaint for this lot.The device was received by a company representative and is in transit to the manufacturing site for investigation.Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A surgeon reported that during a glaucoma filtering shunt implantation procedure, the shunt was showing "no flow" during the surgery after it was implanted into the patient's eye.The surgeon removed the shunt and performed the trabeculectomy procedure without a shunt.The surgeon suspected that the shunt was clogged.In follow up, he indicated that the event was not considered serious and the patient had no harm.

Manufacturer Narrative

The sample has been received and investigated: the shunt was clean and undamaged.The lumen was open.The device history record (dhr) was reviewed and no abnormalities were found.The product was released according to release criteria.There is one similar complaint for this lot.All products pass 100% final inspection prior to approval.If a defect would be noticed, the product would have been rejected.The root cause cannot be determined as no problem had been found: the shunt lumen was found open.(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
• MDR Report Key: 8181687
• MDR Text Key: 131012862
• Report Number: 3003701944-2018-00064
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• PMA/PMN Number: K012852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: 073097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2018
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR