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); Material Protrusion/Extrusion (2979)

Patient Problem Intraocular Pressure Increased (1937)

Event Date 10/01/2016

Event Type  Injury  

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

Event Description

An ophthalmic surgeon reported that five months following a glaucoma filtration device (gfd) implant procedure, it was suspected that the device was clogged.Also at the same time, part of the device started to expose out of the sclera to the conjunctiva.Since the patient's intraocular pressure (iop) was increasing, clogged shunt was suspected.Subsequently, another surgery was performed seven months following the initial procedure to remove the gfd and implant a glaucoma valve.Additional information was requested.

Manufacturer Narrative

Product evaluation: sample was returned for investigation, including only the shunt and without other identification means.Unknown material was seen on the shunt's body and through the port opening and the shunt lumen was found blocked.Therefore, the reported complaint was confirmed.From previous experience the material blocking the device cannot be identified due to two main reasons: the sample is sterilized using gamma radiation which damages the material characteristics.The size of the device does not allow extraction of the material from within its lumen.After cleaning and cutting the shunt, openings on both sides of the restriction unit were seen and no welding penetrations were seen; 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 the manufacturer's 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.Having said that, 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 and no welding penetration were seen, 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: 6258340
• MDR Text Key: 65026453
• Report Number: 3003701944-2017-00017
• 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: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: 072621
• Other Device ID Number: 00380650705013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2016
• 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; Required Intervention
• Patient Age: 85 YR