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

Model Number N/A

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923)

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

Event Date 05/09/2018

Event Type  malfunction  

Event Description

A healthcare professional (hcp) reported that that during the preparation of a cataract surgery, a screw from the objective lens of the opmi lumera i microscope came loose and fell into the patient's eye.The screw was removed from the patient's eye by the scrub nurse.The hcp was able to complete the surgery successfully using the same microscope.There was no injury to the patient due to the reported incident.

• Brand Name: OPMI LUMERA I
• Type of Device: MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC
• 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: william gustafson ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 7580744
• MDR Text Key: 110455807
• Report Number: 9615010-2018-00007
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2015
• 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): Required Intervention