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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number LXT
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2018
Event Type  malfunction  
Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
 
Event Description
A surgeon reported the cassette leaked during a vitrectomy procedure.There is no known harm to the patient.Additional information was requested; however, none has been received to date.This is one of five reports for this facility.
 
Manufacturer Narrative
The lot complaint history was reviewed.This is the seventh complaint for the finished goods lot; however, it is the sixth complaint for this issue for this lot.The device history records shows the product was released per specifications.The reported event was of cassette leakage.However, a sample was not received.Therefore, visual inspection and functional testing of the sample could not be conducted.The root cause of the customer's complaint could not be established as a sample has not been received.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and no root cause could be established.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.(b)(4).
 
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Brand Name
CONSTELLATION 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
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7744685
MDR Text Key116050685
Report Number2028159-2018-01633
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K101285
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLXT
Device Catalogue Number8065751550
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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