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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 8065000095
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Endophthalmitis (1835)
Event Date 03/07/2023
Event Type  Injury  
Event Description
A physician reported that postoperative endophthalmitis was confirmed at consultation on (b)(6) 2023 after vitrectomy surgery on (b)(6) 2023.The vitrectomy surgery was performed again.The sample was not available for return.This report is 1 of the 4 reports.Additional information received from the physician, the patient experienced endophthalmitis in the left eye which led to the hospitalization.The event was treated with antibacterial drugs, eye drops, and an infusion, and the patient was recovering.The changed washing procedure was considered a possible factor.
 
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).
 
Manufacturer Narrative
A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the dhr for the reported suspect product also confirms that this product has been sterilized and all sterilization cycle parameters were verified for acceptability prior to release.No sample was returned for root cause evaluation therefore the condition of the product could not be verified.The system is a closed system.It is operated with a sterile single use consumable cassette, which is designed to isolate the patient fluid path from the console itself.Any reusable surgical instrumentation (e.G.Phaco handpiece) that would come into contact with the patient would be autoclaved by the user prior to surgery, per standard industry practices and the product directions for use (dfu).There is no evidence that the design or performance of the console caused or contributed to this reported event of endophthalmitis.The root cause of the customer's complaint could not be conclusively determined as a sample was not received and the condition of the product could not be verified.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Current tracking indicates no adverse trend for this lot for this event.In-process controls are established to ensure each final assembled cassette is verified that all required tests have been performed and all acceptance criteria are met prior to release.The consumable single-use cassette is provided to the customer in a sterile manner.An evaluation is conducted to ensure each requested item meets customer, process, and regulatory requirements.Quality assurance has reviewed this complaint and 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 SURGICAL PROCEDURE PACK
Type of Device
GENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key16690633
MDR Text Key312790916
Report Number1644019-2023-00378
Device Sequence Number1
Product Code LRO
UDI-Device Identifier00380650000958
UDI-Public00380650000958
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K880961
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 07/18/2023
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 Date07/31/2024
Device Catalogue Number8065000095
Device Lot Number14Y833
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2023
Initial Date FDA Received04/06/2023
Supplement Dates Manufacturer Received06/21/2023
Supplement Dates FDA Received07/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CONSTELLATION VISION SYSTEM
Patient Outcome(s) Required Intervention; Hospitalization;
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