• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - HOUSTONCUSTOM PAKCONVENIENCE KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON - HOUSTON CUSTOM PAK CONVENIENCE KIT   Back to Search Results
Model Number CUSTOM PAK
Device Problem No Known Device Problem
Event Date 08/01/2012
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

An administrator reported that a patient presented with endophthalmitis in the right eye following a cataract with (iol) intraocular lens implant procedure. The surgeon involved had recently "changed up" his surgery technique; he changed from a "retrobulbar block" to topical anesthesia. A nurse consultant who visited the facility spoke with the surgeon. He stated that the patient presented with increased inflammation between post-op days 2 and 5 and was referred to a retina specialist for tap, culture and injection. There were no positive cultures but the patient did respond to antibiotics. The surgeon also stated that the patient had a normal pressure on day 1 but returned on day 3 with a low pressure, indicating that the eye had "leaked" at some point. Additional information has been requested.

 
Manufacturer Narrative

A site visit was performed by a company-recommended nurse consultant. The nurse consultant performed an assessment of the possible causes of endophthalmitis at this facility. Potential causes of endophthalmitis or tass identified at this surgery center either previously by the staff or on the day of the site visit include: inadequate amount of water used to flush the phaco and i&a handpieces with manual flushing; reuse of the rinse/flushing water all day; use of instrument cleaning detergent and enzymatic cleaners in the instrument cleaning process; use of detergent solution to flush the phaco handpiece; possible contamination of homemade y-tubing and syringe used to flush the phaco and i&a handpieces; possible bacterial growth on instruments left sitting on the counter overnight without terminal sterilization; possible cross contamination from instruments from other types of surgery being cleaned at the same time; inadequate maintenance of the ultrasonic cleaner; improper inadequate maintenance of the statim cassettes; stressing the system; use of lidocaine gel or tetravisc prior instilling 5% povidone iodine; use of vancomycin in the bss (balanced salt solution) 500ml; use of preserved epinephrine in the 500ml bss; intraocular use of bss that has been collected from the 500ml bottle; uncapping the connection end of the phaco handpiece cord on the sterile field. The facility was advised to follow the recommended practices for cleaning and sterilizing intraocular surgical instruments from ascrs and asorn. For the custom pak: the customer's complaint history was reviewed for the period of one year; this is one of three complaints reported for this issue. The custom pak lot specific to this event is not known; therefore, lot history and (dhr) device history record review not possible. A sample was not returned for investigation. For the viscoelastic: the lot specific to this event is not known; therefore, lot history and (dhr) device history record review not possible. A sample was not returned for investigation. For the intraocular lens: the product was not returned for analysis. Results from the product history record review indicated the product met release criteria. An investigation has been previously conducted by alcon, which shows no evidence of tass related to our product. The product investigation could not identify a root cause. For the cartridge: the complaint sample was not returned by the reporting facility. Product history records could not be reviewed for the cartridge because the facility did not provide a lot number or any identification traceable to the manufacturing documentation. An investigation has been previously conducted by alcon, which shows no evidence of tass related to our product. For the intraocular lens delivery system: no injector was returned for this report of endophthalmitis. No lot number was identified with the complaint; therefore, a lot history review could not be conducted. The root cause cannot be determined. For the (bss) balanced salt solution: no sample or lot code was provided by the customer. Bss products are terminally sterilized and sterilization cycles are verified for acceptability prior to lot disposition. The root cause of this event cannot be determined. The root cause of the customer's complaint is not known; no samples were returned for evaluation. (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCUSTOM PAK
Type of DeviceCONVENIENCE KIT
Manufacturer (Section F)
ALCON - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section D)
ALCON - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
paul nitschmann
6201 south freeway, r3-16
fort worth , TX 76134
(817) 615 -2440
Device Event Key2782120
MDR Report Key2750534
Event Key2647129
Report Number1644019-2012-00178
Device Sequence Number1
Product CodeKYG
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 08/15/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberCUSTOM PAK
Device Catalogue NumberCUSTOM PAK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/15/2012
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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/14/2012 Patient Sequence Number: 1
#TreatmentTreatment Date
INFINITI VISION SYSTEM OZIL
PIK PAK
DUOVISC
SN60WF INTRAOCULAR LENS
MONARCH II C CARTRIDGE
MORNACH II HANDPIECE
BALANCED SALT SOLUTION
-
-