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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS IFS; FEMTOSECOND LASER
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ABBOTT MEDICAL OPTICS IFS; FEMTOSECOND LASER Back to Search Results
Model Number J20007K
Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2015
Event Type  malfunction  
Event Description
The customer reported a strong burning smell with the intralase femtosecond laser.The screen displayed a message asking to be powered down.There was no patient involvement.
 
Manufacturer Narrative
(b)(6).
 
Manufacturer Narrative
(b)(6).All pertinent information available to abbott medical optics at the time of this report has been submitted.
 
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Brand Name
IFS
Type of Device
FEMTOSECOND LASER
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA
Manufacturer (Section G)
ABBOTT MEDICAL OPTICS INC.
510 cottonwood drive
milpitas CA 95035
Manufacturer Contact
valerie sedzicki
1700 east st. andrew place
santa ana, CA 92705
7142478567
MDR Report Key4889325
MDR Text Key6023976
Report Number3006695864-2015-00361
Device Sequence Number1
Product Code HNO
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K060372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberJ20007K
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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