MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG OMNI LUMERA 700; MICROSCOPE, OPHTHALMIC, OPERATING ...

Model Number 700

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Capsular Bag Tear (2639)

Event Date 11/12/2014

Event Type  Injury  

Event Description

The xenon lamp of the opmi lumera 700 microscope went out twice during an ophthalmic surgery.The surgeon removed the instruments from the patient's eye when the light went out and continued the surgery when the light came back on.The surgeon reported that a posterior capsular bag rupture was noticed after the light came back on for the second time.The surgeon made a decision to implant an alternative sulcus iol lens which can be implemented without a capsular bag.

Manufacturer Narrative

The manufacturer inspected the affected device and could not reproduce the reported light failure when simulating potential customer light scenarios.No malfunction was found and the device meets manufacturer's specification.The user manual advises to perform a complete functional test prior to each surgery.The manual also informs about the easy option of switching to the backup lamp, which was no intended in this case.The user manual advises also that the customer has to have available an independent operational lamp in case that the light system of the microscope would fail.

Event Description

The health care professional reported: a subsequent yag laser capsulotomy was performed to address clouding of the remaining capsule.

• Brand Name: OMNI LUMERA 700
• Type of Device: MICROSCOPE, OPHTHALMIC, OPERATING ...
• Manufacturer (Section D): CARL ZEISS MEDITEC AG; oberkochen ; GM
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN SITE); rudolf-eber-strasse 11; oberkochen ; GM
• Manufacturer Contact: judy brimacombe ; 5160 hacienda drive; dublin, CA 94568 ; 9255574616
• MDR Report Key: 4379973
• MDR Text Key: 15969048
• Report Number: 9615010-2014-00017
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 700
• Device Catalogue Number: 305953-9900-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other