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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT)

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ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 1699-64
Device Problem Insufficient Information (3190)
Patient Problems Endophthalmitis (1835); Pain (1994); Loss of Vision (2139)
Event Date 05/19/2018
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 nurse informed a company representative that they had an endophthalmitis case from last week's procedures. The patient reported pain in the eye four days postoperatively then the retina surgeons took over the patient's care. The surgeon indicated the patient was a mulch farmer and went to work the same day of his surgery. Additional information was received from the surgeon. He reported the patient underwent an uncomplicated cataract removal with intraocular lens implant of the left eye. The patient contacted the surgeon on five days after the initial procedure reporting "pain and loss of vision". An aqueous and vitreous tap was performed and the patient was prescribed fortified antibiotics solutions to take every hour. The patient underwent a pars plana vitrectomy (ppv) procedure with a repeat vitreous culture at one week after the initial procedure. All cultures indicated no growth and no organisms. The surgeon indicated the patient has been experiencing fairly severe pain since the onset of the endophthalmitis and a persistent corneal epithelial defect since the ppv. Also, he indicated "poor prognosis at this point for normal vision". The staff could not provide information as to product(s) which were suspect as the cause of the reported event.

 
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Brand NameCUSTOM-PAK SURGICAL PROCEDURE PACK
Type of DeviceGENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON RESEARCH, LTD. - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7626833
MDR Text Key111946876
Report Number1644019-2018-00154
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1699-64
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
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: 06/21/2018 Patient Sequence Number: 1
Treatment
ACRYSOF IQ IOL WITH ULTRASERT DELIVERY SYSTEM; BROMSITE SOLUTION; DUOVISC VISCOELASTIC SYSTEM; INFINITI VISION SYSTEM; POLYTRIM SOLUTION; PREDNISOLONE ACETATE 1% SOLUTION; UNSPECIFIED EPINEPHRINE; UNSPECIFIED IRRIGATION SOLUTION; VIGAMOX; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
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