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

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Visual Impairment (2138)

Event Date 10/23/2018

Event Type  Injury  

Event Description

A health care professional (hcp) reported that there had 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 has been performed to correct the patient's vision.

Manufacturer Narrative

Additional information was received on 7/17/2019 the manufacturer reviewed the patient's pre- and post-op measurement data and the iol calculation printouts from the device.The printouts shows that the iolmaster identified the cornea signal incorrectly.The printouts indicate that there is no measurement mark on the front surface of the cornea, as well as at the back surface of the cornea.Furthermore, there is no measurement mark at the back surface of the natural lens.Those missing lines are reflected in the red measuring marks for those measurements.Also, the axial length measurement has an exclamation mark.In addition, the iolmaster displayed a warning message concerning unusual biometry conditions.The recommended cross-check of measurements for plausibility and correct position of measurement marks as written in the instructions for use was not performed by the user.The user has received an application training.Descriptions of changes: field g7: updated to "follow-up #: 1"; field h2: entered "device evaluation" ; field h3: updated to "yes, evaluation summary attached"; field h6: updated method to "10".Updated result code to "213".Updated conclusion code "18".Field h10: added manufacturer narrative and added descriptions of changes.

• 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
• MDR Report Key: 8190294
• MDR Text Key: 131179948
• Report Number: 9615030-2018-00013
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• PMA/PMN Number: K122418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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: 000000-1932-169
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention