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

Model Number 700

Device Problem Use of Device Problem (1670)

Patient Problem Visual Impairment (2138)

Event Date 11/13/2023

Event Type  Injury  

Manufacturer Narrative

Cause for the incorrect measurement mark could be the low snr (signal-to-noise ratio) due to the misaligned delay prism or the dense cataract of the patient measured.There were multiple warning messages on the printouts regarding fixation check and unusual measurement values.The recommended cross-check of measurements for plausibility and correct position of measurement marks was not performed by the user.In addition, the warning messages in the device gui were not observed by the user.Therefore, it can be concluded that the unexpected surgical outcome occurred due to user error.

Event Description

Customer reported they had a patient with a refractive surprise after surgery due to the iolmaster 700 showing the densest part of the cataract as the end of the capsule.A re-implantation was performed.

• 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 07745 ; GM 07745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9255574100
• MDR Report Key: 18478057
• MDR Text Key: 332461231
• Report Number: 9615030-2023-00022
• Device Sequence Number: 1
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)20181101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• 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: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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