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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

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ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065830047
Device Problem Suction Problem (2170)
Patient Problem Retinal Tear (2050)
Event Date 05/28/2020
Event Type  Injury  
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 while the actuation of the cutter probe had been confirmed, the aspiration was poor during surgery.Therefore, had to move close to the retina, causing a hole to be made in the retina.The surgery was completed.The procedure type is unknown.The sales representative, commented that the surgery was completed after laser emitted to the hole within the same procedure.
 
Manufacturer Narrative
One opened probe was received with tip protector, in a tray along with other items, for the report of aspiration failure.The returned sample was visually inspected and found to be non-conforming with a large amount of orange/brown foreign material on the needle and inside of the port.The sample was then functionally tested for actuation and aspiration and was found to be conforming for both functional tests.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The returned sample was found to be functionally conforming, therefore an aspiration failure as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the returned probe was functionally conforming.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CONSTELLATION SURGICAL PROCEDURE PACK
Type of Device
GENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
MDR Report Key10148199
MDR Text Key194950371
Report Number1644019-2020-00287
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Catalogue Number8065830047
Device Lot Number2239960H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2020
Initial Date Manufacturer Received 05/29/2020
Initial Date FDA Received06/12/2020
Supplement Dates Manufacturer Received08/29/2020
Supplement Dates FDA Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CONSTELLATION,TABLETOP,JAPAN,; CONSTELLATION,TABLETOP,JAPAN,
Patient Outcome(s) Required Intervention;
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