MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) OPMI LUMERA I; MICROSCOPE, OPHTHALMIC, OPERATING

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Optical Problem (3001)

Patient Problems Rupture (2208); Capsular Bag Tear (2639)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

The hcp communicated that when the surgeon maneuvered the device during the case, the plug connected to the stand was dislodged enough to lose power.

Event Description

A healthcare professional (hcp) reported that during a case the power cord disconnected from the device.The device's power and light went out, which caused the doctor to rupture the patient's posterior eye capsule.The doctor had to do an anterior vitrectomy while the patient was under local monitored anesthesia.

Manufacturer Narrative

Updated h2 to "correction".Added missing file attachment to h10.

• Brand Name: OPMI LUMERA I
• Type of Device: MICROSCOPE, OPHTHALMIC, OPERATING
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• MDR Report Key: 9771886
• MDR Text Key: 181479913
• Report Number: 9615010-2020-00003
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 305946-9900-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention