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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION

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ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065750833
Device Problems Device Emits Odor (1425); Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
 
Event Description
A customer reported that a burning smell was noticed and that the system shut off on its own.During a follow-up phone call, the reporter was unable to provide additional details of the event but assured that no patients were impacted.
 
Manufacturer Narrative
The system was examined and the reported ¿shut off¿ issue was confirmed.The host was replaced to address the issue.The company representative did not indicate finding anything related to the reported ¿burning smell¿.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.Based on qa assessment, the product met specifications at the time of release.A host module was received for evaluation.A visual assessment of the returned host module did not reveal any non-conformity.The returned host module was installed onto a calibrated system.The system was turned on and allowed to boot.Burning smell occurred and the system could not boot.The returned host module was trouble shot.Trouble-shooting traced to an electrical short from the 3 line to ground on the mother board and burned the host power pcba in the returned host module.The root cause of the reported events can be attributed to non-conforming mother board, which had an electrical short and burned the host power pcba in the returned host module.(b)(4).
 
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Brand Name
INFINITI VISION SYSTEM
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer (Section G)
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer Contact
eddie darton, md, jd
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686660
MDR Report Key5042870
MDR Text Key25249014
Report Number2028159-2015-08013
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120912
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other
Type of Report Followup
Report Date 10/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065750833
Other Device ID Number2.06
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/28/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received10/02/2015
Date Device Manufactured04/26/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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