MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) IOLMASTER 700

Model Number 700

Device Problem Insufficient Information (3190)

Patient Problem Visual Impairment (2138)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

The most possible root cause cannot be determined based on the available information.

Event Description

As reported by the user facility: per medwatch (b)(4): describe the event or problem: "patient was intubated on continuous fentanyl infusion.Patient receiving a bronchoscopy at bedside.Infusion continuously alarming "air in line".Tubing removed from pump and no air bubbles visualized.Patient received a prn dose of fentanyl and versed due to patient becoming agitated during procedure." no injury reported.

• Brand Name: IOLMASTER 700
• Type of Device: IOLMASTER 700
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 18895973
• MDR Text Key: 337573880
• Report Number: 9615030-2024-00004
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: 000000-1932-169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2018
• 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