MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) OPMI LUMERA 700

Catalog Number 305953-9900-000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Corneal Edema (1791)

Event Date 07/28/2017

Event Type  Injury  

Event Description

The health care professional (hcp) reported the following: during vitrectomy for retinal detachment, neither the foot control panel buttons nor the manual knobs would work for focusing the microscope's resight viewing system.Troubleshooting the issue delayed the procedure, which resulted in the development of corneal edema in the patient's eye.To improve visibility for attaching the retina, the hcp performed an unplanned corneal epithelial debridement.

• Brand Name: OPMI LUMERA 700
• Type of Device: LUMERA 700
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• MDR Report Key: 6871297
• MDR Text Key: 86428666
• Report Number: 9615010-2017-00009
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 305953-9900-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other