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

Catalog Number ALCUNK00059

Device Problem Defective Device (2588)

Patient Problem Fibrosis (3167)

Event Type  Injury  

Manufacturer Narrative

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.Literature: creagmile j et al,hydrus microstent implantation with omni surgical system ab interno canaloplasty for the management of open-angle glaucoma in phakic patients refractory to medical therapy; american journal of ophthalmology case reports 29 (2023) 101749.The manufacturer internal reference number is: (b)(4).

Event Description

A literature article published with a purpose to report a series of 8 phakic eyes of 8 patients with open angle glaucoma with uncontrolled intraocular pressure on maximum tolerable medical therapy receiving company microstent implants combined with concomitant omni surgical system ab interno canaloplasty.A 37-year-old asian male with juvenile open angle glaucoma (joag) was referred to the glaucoma service for evaluation and management.In the operative eye, the patient had a pre-treatment maximum iop of 40 mmhg, and examination revealed c/d of 0.9 with inferior rim thinning.Gonioscopy was significant for a 1 clock hour patch of inferior peripheral anterior synechiae (pas) inferiorly, as well as postoperative changes from previous glaucoma surgery (described below).Hvf demonstrated an md of - 17.53 db, a psd of 11.73 db, and a dense superior arcuate defect.Oct (optical coherence tomography) revealed an average rnfl (retinal nerve fiber layer) thickness of 59m with a superior thickness of 60m and an inferior thickness of 57m.Ganglion cell analysis (gca)showed a global ganglion cell inner plexiform layer (gcipl) thickness of 64m.The patient had a past history of trabeculectomy and iridectomy with mitomycin c, which subsequently fibrosed and failed.The patient then underwent repeat trabeculectomy with company shunt placement which again failed due to aggressive fibrosis.There are two medical device reports associated with this patient.This report is associated with the company model shunt type.Literature: creagmile j et al,hydrus microstent implantation with omni surgical system ab interno canaloplasty for the management of open-angle glaucoma in phakic patients refractory to medical therapy; american journal of ophthalmology case reports 29 (2023) 101749.

Manufacturer Narrative

No data regarding product identity was received i.E.No lot or serial number were indicated for the event therefore a complaint history review, non-conformance review and dhr review could not be performed.A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be evaluated.A root cause for the customers reported event could not be determined as no sample was received at investigation site.No supporting data was presented, obtained or identified while investigation concluding product contributing factors are related to the event.Product malfunction or cause could not be determined with relation to the event.Relationship of the product to the event is unclear.Reported event could not be conformed.Complaint is related to literature.Manufacturing site investigations include the review and inspection of the technical aspect of the company gfd (glaucoma filtration device) product.Reported event includes mainly results of company gfd product implementation.Article does not emphasize the technical scenarios of events or issues relating specifically to the company product.However mainly mentions the device implementation as one of the glaucoma treatments.No data regarding products identity nor product samples were received.Due to the above, no additional action can be executed by manufacturing site.Addition follow up for related event codes will be made during the annual post production risk review (pprr).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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17425053
• MDR Text Key: 320056476
• Report Number: 3003701944-2023-00015
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ALCUNK00059
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Male