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

Model Number	700
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The most possible root cause cannot be determined based on the available information.There is no information that reasonably suggests that there was a malfunction of the zeiss device that could have contributed to the reported unexpected surgical outcome.A number of factors not related to the lolmaster may have influenced the surgical outcome.Not all are controlled by the manufacturer.Note: the customer indicated that they acquired the device from a third-party reseller.
Event or Problem Description
The customer reported that their iolmaster 700 is measuring the cylinder (cyl) value 1.5 diopters higher than expected.A lens reimplantation was performed for one 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 07745 ; GM 07745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); goeschwitzer-strasse 51-52; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 24591210
• Report Number: 9615030-2026-00016
• Device Sequence Number: 9531552
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)220501
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2026

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: 02/11/2026
• Supplement Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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 Sex: Unknown