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 09/23/2016

Event Type  Injury  

Manufacturer Narrative

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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.Additional information was requested and received.(b)(4).

Event Description

A surgeon reported that two days after a glaucoma filtering shunt was implanted, the intraocular pressure (iop) was increased.A sutured was then lysed and three weeks later a needling procedure was performed, but the iop remained high and the filtering bleb was not formed.The patient was taken back to surgery and the scleral flap was lifted.The surgeon observed that there was no aqueous flow through the shunt.The shunt was explanted and a trabeculectomy was performed.Four days later the symptoms were improved.

Manufacturer Narrative

Corrected information was provided.The manufacturer internal reference number is: (b)(4).

Event Description

Upon review of previous information received, it was also indicated that two days prior to the shunt explant, the patient was started on a glaucoma eye drop medication.

Manufacturer Narrative

Shunt alone was returned for investigation in a non-original outer box.After cleaning the device the blockage was removed.Light passed through both sides of the restriction unit; therefore, there is no indication for manufacturing related factors that could cause the blockage.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.Having said that, one may conclude that the blockage was formed after the product left the manufacturing plant.The root cause is inconclusive ¿ product met specifications, since the blockage was confirmed, and could have been caused by many different reasons after the clinical procedure.Therefore, there is no evidence for an inherent defect that might have caused the event.(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: 6049584
• MDR Text Key: 58133346
• Report Number: 3003701944-2016-00196
• 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,Followup
• Report Date: 12/24/2016

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 Expiration Date: 06/30/2019
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: 072632
• Other Device ID Number: 00380650705013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/31/2016; 12/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2016
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 80 YR