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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065752438
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Edema (1791); Endophthalmitis (1835); Intraocular Pressure Increased (1937); Pain (1994)
Event Date 08/27/2020
Event Type  Injury  
Manufacturer Narrative

The lot complaint history and device history record were not reviewed as no lot information was available for this complaint. The sample was not received at the investigating site for this complaint report; visual inspection or functional testing could not be conducted. If a sample is returned at a later date, the investigation will be reopened and the sample will be evaluated. The root cause of the customer's complaint could not be established as a sample has not been received. Without analysis of the sample, it is not possible to isolate the root cause. As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined. After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and no root cause could be established. The manufacturer internal reference number is: (b)(4).

 
Event Description

A customer reported a patient experienced endophthalmitis in the left eye with pain, diffuse corneal edema, elevated intraocular pressure following a retina procedure two days after an uncomplicated cataract procedure. Four days after the retina procedure, an anterior chamber tap was performed combined with injection of an antibiotic and steroid. The patient's condition is improving. This is one of two reports from this facility.

 
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Brand NameCONSTELLATION SURGICAL PROCEDURE PAK
Type of DeviceGENERAL 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
8175514979
MDR Report Key10614376
MDR Text Key209422376
Report Number1644019-2020-00533
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 10/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8065752438
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/01/2020 Patient Sequence Number: 1
Treatment
CEFTAZIDINE INJECTION; CONSTELLATION VISION SYSTEM; VANCOMYCIN INJECTION
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