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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER PUREPOINT LASER; LASER, OPHTHALMIC
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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER PUREPOINT LASER; LASER, OPHTHALMIC Back to Search Results
Catalog Number 8065750597
Device Problems Device Emits Odor (1425); Self-Activation or Keying (1557)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/23/2019
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 the equipment turned itself off and had a smell of burnt material before a procedure.There were no error messages displayed.There was no patient impact.
 
Manufacturer Narrative
The company service representative examined the system but was unable to replicate the reported event.Preventative maintenance (pm) was performed.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported event 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, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
MDR Report Key8705607
MDR Text Key148542459
Report Number2028159-2019-01104
Device Sequence Number1
Product Code HQF
Combination Product (y/n)N
PMA/PMN Number
K062624
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/20/2020
Device Catalogue Number8065750597
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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