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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number TABLETOP
Device Problem Intermittent Energy Output (4025)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2022
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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported that during a surgery an ophthalmic console exhibited intermittent laser firing.Procedure was completed after rebooting the system.There was no harm to the patient.Additional information received clarified that event happened during a cataract and vitrectomy surgery.
 
Manufacturer Narrative
The company service representative examined the system and was unable to confirm or replicate the reported event.As a preventative measure, the floating printed circuit board (pcb) was replaced.The system was then tested and met all product specifications.A system manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The system was found to have no problem; therefore, the root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CONSTELLATION VISION SYSTEM
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer (Section G)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key13730419
MDR Text Key286989938
Report Number2028159-2022-00337
Device Sequence Number1
Product Code HQC
UDI-Device Identifier00380657511501
UDI-Public00380657511501
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K101285
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTABLETOP
Device Catalogue Number8065751150
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/17/2022
Initial Date FDA Received03/11/2022
Supplement Dates Manufacturer Received05/11/2022
Supplement Dates FDA Received06/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2013
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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