MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) IOLMASTER 700; BIOMICROSCOPE, SLIT-LAMP, AC-POWERED

Model Number 700

Device Problem Incorrect Measurement (1383)

Patient Problem Visual Impairment (2138)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer evaluated the log files provided by the hcp.Based on the analysis of the log files, it can be confirmed that the event occurred due to user error.The operator measured patient b and c while patient a was still selected.This caused measurements to be mistakenly assigned to the incorrect patient.Unfortunately, the user error was not detected by the operator, although the patient data of patient a was displayed in gui during measurement, analysis and iol calculation workflow and the inconsistency of measurement data would have been obvious when comparing the different datasets of the patient.

Event Description

A health care professional (hcp) reported that there has been an incorrect surgical result after using the iolmaster 700 for the biometry measurements and lens power calculations.The hcp reported that a lens exchange will be performed to correct the patient's vision.

• Brand Name: IOLMASTER 700
• Type of Device: BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
• 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: viet nguyen ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 11362543
• MDR Text Key: 233038832
• Report Number: 9615030-2021-00003
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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: 01/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2014
• 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
• Patient Age: 77 YR