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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - BELGIUM/ ALCON NV CUSTOM PAK; CONVENIENCE KIT

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ALCON - BELGIUM/ ALCON NV CUSTOM PAK; CONVENIENCE KIT Back to Search Results
Model Number CUSTOM PAK
Device Problem Dull, Blunt (2407)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A pharmacist reported that a knife was noted to be blunt prior to surgery.There was no pt involvement.Add'l info has been requested.
 
Manufacturer Narrative
No sample was returned for the report of a blunt, defective knife.The final customer lot was identified as 985431m, mfg on 10/29/2014.For this final lot, one component knife lot, 981769m mfg in september 2014, was used to make up the final lot.A device history record review for each of the knife lots was conducted.No anomaly was found during the device history record reviews.The prod was released based on the mfr's acceptance criteria.No add'l investigation is required based on device history review.A complaint history review indicates no add'l complaints were associated with the knife lots.The root cause for the defect experienced by the customer cannot be determined.All knives are 100% inspected by trained operators using a minimum of 10x magnification during mfg.Nonconformances, such as a damaged tip or cutting edge described in the complaint, are removed from the lot and scrapped.Functional testing is performed and monitored during the finishing process to ensure the sharpness of the prod.(b)(4).
 
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Brand Name
CUSTOM PAK
Type of Device
CONVENIENCE KIT
Manufacturer (Section D)
ALCON - BELGIUM/ ALCON NV
medialaan 36
vilvoorde B-180 0
BE  B-1800
Manufacturer (Section G)
ALCON - BELGIUM/ ALCON NV
medialaan 36
vilvoorde B-18 00
BE   B-1800
Manufacturer Contact
janet moran
6201 s freeway
r3-48
fort worth, TX 76134
8176152742
MDR Report Key4534882
MDR Text Key5520332
Report Number3002037047-2015-00047
Device Sequence Number1
Product Code KYG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2016
Device Model NumberCUSTOM PAK
Device Catalogue NumberCUSTOM PAK
Device Lot Number411138
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/23/2015
Initial Date FDA Received02/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
CLEARCUT HP2 DB SLIT 2.2MM ANG
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