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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARL ZEISS MEDITEC INC. IOL MASTER 700; BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
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CARL ZEISS MEDITEC INC. IOL MASTER 700; BIOMICROSCOPE, SLIT-LAMP, AC-POWERED Back to Search Results
Model Number IOL MASTER 700
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/22/2020
Event Type  malfunction  
Event Description
Zeiss iol master 700 has a keratometry part.There are many internal lens.The lens are poorly mounted.One of the lens fell during battery replacement.If it is slightly loose but not dislocated yet, it might not be detected, and can cause wrong calculation and result wrong intraocular lens to be implanted into human eye.On (b)(6) 2020 replacement of internal battery of zeiss iol master 700, result: internal keratometry lens fell.Internal lens of keratometer was poorly mounted.The zeiss iol master 700 has a keratometry which has multiple internal lens.One of them fell during attempted battery replacement by zeiss tech phillip.One of the inferior lens fell.If it is partially loose or dislocated, it can cause wrong calculation.Fda safety report ids# (b)(4).
 
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Brand Name
IOL MASTER 700
Type of Device
BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
Manufacturer (Section D)
CARL ZEISS MEDITEC INC.
dublin CA
MDR Report Key10396126
MDR Text Key202742783
Report NumberMW5096020
Device Sequence Number1
Product Code HJO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 08/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIOL MASTER 700
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Weight45
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