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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER PUREPOINT LASER; LASER, OPHTHALMIC

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ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER PUREPOINT LASER; LASER, OPHTHALMIC Back to Search Results
Catalog Number 8065750597
Device Problem Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/21/2017
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 "no tissue" burning effect when firing the laser.During a follow up, the customer reported that during the laser treatment it did not appear that the laser was working (no change to the tissue).They tested the laser with tissue paper and was not able to see any laser marks on the tissue paper.They cancelled the patient procedure.The procedure will be rescheduled once the system has been serviced.There was no patient harm.
 
Manufacturer Narrative
The company service representative examined the system but was unable to replicate the reported event.The system was then tested and met all product specifications.The system was manufactured on september 2, 2009.Based on qa assessment, the product met specifications at the time of release.A review of complaints for the last 24 months did not indicate any additional related reports for this system serial number.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
PUREPOINT LASER
Type of Device
LASER, OPHTHALMIC
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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6953094
MDR Text Key90521492
Report Number2028159-2017-04076
Device Sequence Number1
Product Code HQF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062624
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065750597
Other Device ID Number1.04_BLD_0043
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2009
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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