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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 Date 03/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer did not request for a field service specialist visit to the site.An accessory exchange was requested.The handpiece was not under warranty and it was not returned to amo.All pertinent information available to abbott medical optics has been submitted.
 
Event Description
The customer reported that the ellips fx phaco handpiece colored wires were exposed.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 Key5543366
MDR Text Key41717857
Report Number3006695864-2016-00335
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeFR
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 04/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2016
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 Received03/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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