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U.S. Department of Health and Human Services

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

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CARL ZEISS MEDITEC AG (JENA) IOLMASTER 700 Back to Search Results
Model Number 700
Device Problem Insufficient Information (3190)
Patient Problem Visual Impairment (2138)
Event Date 02/02/2024
Event Type  Injury  
Event Description
Repeatable myopic error of approximately 2 to 2.5 diopters in patient after cataract surgery was reported.This has resulted in the need for re-operation.No further details have been provided at this time.
 
Manufacturer Narrative
The most possible root cause cannot be determined based on the available information.
 
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Brand Name
IOLMASTER 700
Type of Device
IOLMASTER 700
Manufacturer (Section D)
CARL ZEISS MEDITEC AG (JENA)
carl zeiss promenade 10
jena, thueringia 7745
GM  7745
Manufacturer (Section G)
CARL ZEISS MEDITEC AG (JENA)
carl zeiss promenade 10
jena, thueringia 7745
GM   7745
Manufacturer Contact
manjaya hegde
5300 central parkway
dublin, CA 94568
9252164697
MDR Report Key18896623
MDR Text Key337581094
Report Number9615030-2024-00010
Device Sequence Number1
Product Code HJO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170171
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number700
Device Catalogue Number000000-1932-169
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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