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

Model Number N/A

Device Problems Use of Device Problem (1670); Installation-Related Problem (2965)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2019

Event Type  malfunction  

Event Description

During inspection of the device, a czmi field service engineer (fse) discovered that the opmi lumera t had a light module installed which is not intended for ophthalmic surgeries.

• Brand Name: OPMI LUMERA T
• Type of Device: OPMI LUMERA T
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer Contact: vernon brown ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 8465466
• MDR Text Key: 140340984
• Report Number: 9615010-2019-00001
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 302608-9011-000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1