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

Model Number	700
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer in thailand reported that the iolmaster 700 seems to have unstable values.The values did not match the values taken from other hospitals in the same patient case.A demo machine was brought in by zeiss service to compare and found that the calculation results were different about 1 diopter.The measured axial length value is longer by an average of about 0.23-0.27 mm compared to the demo unit and other units in the hospital.This will cause the calculation of the artificial lens value to be incorrect by about 0.5-1.0 d.Patient data was requested.There is no information about negative impact to a patient (lens re-implantation).
Additional Manufacturer Narrative
The root cause for the unexpected calculation outcomes and the axial length measurement values being too high was a device malfunction caused by a zeiss service engineer performing invalid procedures on the device.The measuring head of this iolmaster 700 in thailand was replaced on (b)(6) 2021.Presumably the device settings of the new measuring head were overwritten with the old device settings.
Additional Manufacturer Narrative
The customer confirmed that there was no adverse event observed related to the malfunction.The device was repaired onsite.Before the device was put back into service, the latest service package and the system checkout protocol were reviewed by 2nd level support specialist.All test eye readings for keratometry, oct length, oct deflection, white to white, optical axis are within tolerance.The small deviations in the reference values are still in tolerance and have no impact to measurements on human eyes.The device works according to the manufacturer specifications.The device can be used again by the customer.The respective field service engineer was re-trained.

• Brand Name: IOLMASTER 700
• Common Device Name: IOLMASTER 700
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thuringia 07745 ; GM 07745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promende 10; jena, thuringia 07745 ; GM 07745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 20646149
• Report Number: 9615030-2024-00022
• Device Sequence Number: 7366871
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)190501
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K170171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown