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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - BELGIUM/ALCON N.V. CUSTOM PAK; CONVENIENCE KIT
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ALCON - BELGIUM/ALCON N.V. CUSTOM PAK; CONVENIENCE KIT Back to Search Results
Model Number CUSTOM PAK
Device Problem Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2015
Event Type  malfunction  
Event Description
An ophthalmic surgeon reported that a knife did not cut well and required additional effort to make the incision during surgery.Pt impact is unk.Additional information has been requested.
 
Manufacturer Narrative
The customer did not return a sample for evaluation.No lot information was provided, therefore a device history record review and complaint history review could not be conducted.The root cause for the customer complaint issue cannot be determined.All knives are 100 percent visually inspected and tested for penetration during manufacturing.(b)(4).
 
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Brand Name
CUSTOM PAK
Type of Device
CONVENIENCE KIT
Manufacturer (Section D)
ALCON - BELGIUM/ALCON N.V.
medialaan 36
vilvoorde B-180 0
BE  B-1800
Manufacturer (Section G)
ALCON - BELGIUM/ALCON N.V.
medialaan 36
vilvoorde B-18 00
BE   B-1800
Manufacturer Contact
janet moran
6201 south freeway, r3-48
fort worth, TX 76134
8176152742
MDR Report Key4524790
MDR Text Key5492940
Report Number3002037047-2015-00043
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 Other
Type of Report Initial
Report Date 01/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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
Date Manufacturer Received01/28/2015
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 Unknown
Patient Sequence Number1
Treatment
CLEARCUT SB INTREPID 2.4 ANG
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