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

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	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Health care professional reported measurement discrepancies and refractive surprise on a patient.The doctor will be doing iol exchange to correct patient's vision.
Additional Manufacturer Narrative
Three good faith efforts were made to obtain missing information from the customer in order to complete the investigation; however, the customer was unresponsive.The most possible root cause cannot be determined based on the available information.A number of factors not related to the iolmaster may have influenced the measurements.Not all are controlled by the manufacturer.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.Description of changes: field b4: added "date of this report" 10/06/2025.Field g3: updated "date received by manufacturer" to "09/11/2025".Field g6: checked "30 days", updated to "follow-up, # 1".Field h2: added "additional information", "device evaluation" field h6: added investigation findings code "213", investigation conclusion code"4315".Field h11: added manufacturer narrative.Added description of changes.

• Brand Name: IOLMASTER 700
• Common Device Name: IOLMASTER 700
• 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 manjaya ; 5300 central parkway; dublin, CA 94568 ; 9255574259
• MDR Report Key: 21654404
• Report Number: 9615030-2025-00006
• Device Sequence Number: 20707587
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)210201
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: 000000-1932-169
• Device Lot Number: N/A
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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: 77 YR
• Patient Sex: Female