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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS ELLIPS FX PHACO HANDPIECE
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ABBOTT MEDICAL OPTICS ELLIPS FX PHACO HANDPIECE Back to Search Results
Model Number 690880
Device Problem Peeled/Delaminated (1454)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).Customer did not request for a field service specialist visit to the site.Only an accessory exchange was requested.All pertinent information available to abbott medical optics has been submitted.
 
Event Description
The customer reported cord damaged /exposed colored wires with the ellips phaco handpiece.There was no patient involvement reported.
 
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Brand Name
ELLIPS FX PHACO HANDPIECE
Type of Device
PHACO HANDPIECE
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA
Manufacturer (Section G)
ABBOTT MEDICAL OPTICS INC.
510 cottonwood drive
milpitas CA 95035
Manufacturer Contact
lourdes guevara
1700 east st. andrew place
santa ana, CA 92705
7142478497
MDR Report Key5722086
MDR Text Key47286364
Report Number3006695864-2016-00607
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K060366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 06/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number690880
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
SIGNATURE SYSTEM, SN (B)(4)
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