MAUDE Adverse Event Report: OCULAR INSTRUMENTS IPRISM; GONIOPRISM

Model Number 10820

Device Problem Insufficient Information (3190)

Patient Problem Endophthalmitis (1835)

Event Date 03/10/2014

Event Type  Injury  

Event Description

Endophthalmitis in the eye.

• Brand Name: IPRISM
• Type of Device: GONIOPRISM
• Manufacturer (Section D): OCULAR INSTRUMENTS; 2255 116th ave., n.e.; bellevue WA 98004
• Manufacturer Contact: 2255 116th ave., n.e.; bellevue, WA 98004 ; 4254555200
• MDR Report Key: 3748361
• MDR Text Key: 4483179
• Report Number: 3014865-2014-00001
• Device Sequence Number: 1
• Product Code: HKS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2014

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
• Device Operator: Health Professional
• Device Model Number: 10820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ISTENT
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 76 YR