MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC AHMED GLAUCOMA VALVE; GLAUCOMA SHUNT

Model Number	FP8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure, Delayed, Uncontrolled (1936)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The doctor stated that he placed extra sutures on the scleral graft to minimize peri-tubular outflow, leave viscoelastic in the eye and atropinize the patient.Lot number is not available for dhr review.Valve was not explanted and available for evaluation.Ifu was reviewed and it includes shallow chamber as a known complication and adverse reaction.The patient has improved and stabilized.
Event or Problem Description
(b)(6) year old monocular patient - placed an fp8, left viscoelastic in chamber and treated with atropine.Chamber was moderately shallow with compromised vision d1.Doctor ended up injecting her with viscoelastic on day 6 due to continued shallow ac.She is making slow visual recovery.

• Brand Name: AHMED GLAUCOMA VALVE
• Common Device Name: GLAUCOMA SHUNT
• Manufacturer (Section D): NEW WORLD MEDICAL, INC; 10763 edison court; rancho cucamonga CA 91730
• MDR Report Key: 8553112
• Report Number: 1000125279-2019-00035
• Device Sequence Number: 11198449
• Product Code: KYF
• UDI-Device Identifier: 00892064002126
• UDI-Public: (01)00892064002126
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: FP8
• Device Catalogue Number: FP8
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention