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

Model Number	700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the iolmaster 700 device made incorrect measurements for a patient.The patient had 5 measurement sessions on the device.The user implanted an iol (intraocular lens) based on measurements from (b)(6) 2025 which resulted in a highly hyperopic astigmatic outcome.The user is planning an iol exchange for the patient.

• Brand Name: IOLMASTER 700
• Common Device Name: BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); goeschwitzer strasse 51-52; jena, thueringia 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); goeschwitzer strasse 51-52; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: manjaya manjaya ; 5300 central parkway; dublin, CA 94568 ; 9255574259
• MDR Report Key: 24087315
• Report Number: 9615030-2026-00001
• Device Sequence Number: 17596409
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)230201
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K173771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 700
• Device Catalogue Number: 000000-2522-320
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic