K-3000 MICROKERATOME BLADES 378607

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-07-18 for K-3000 MICROKERATOME BLADES 378607 manufactured by Bd Ophthalmic Systems.

Event Text Entries

[216663] Customers reported that: the blade assemblies were difficult to insert into the keratome head. The blade assemblies at times failed to oscillate properly, and may have resulted in an undersirable surgical outcome. Most difficulties were experienced during the blade test phase (not on patient).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226073-2001-00004
MDR Report Key343179
Report Source05,06
Date Received2001-07-18
Date of Report2001-07-17
Report Date2001-07-17
Date Mfgr Received2001-06-26
Device Manufacturer Date2000-10-01
Date Added to Maude2001-07-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactPAT FILOSA
Manufacturer Street411 WAVERLEY OAKS ROAD BLDG. 2, SUITE 229
Manufacturer CityWALTHAM MA 02452
Manufacturer CountryUS
Manufacturer Postal02452
Manufacturer Phone7819067917
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameK-3000 MICROKERATOME BLADES
Generic NameKERATOME BLADES
Product CodeHMY
Date Received2001-07-18
Model NumberNA
Catalog Number378607
Lot NumberM20219-00829
ID NumberNA
Device Expiration Date2003-10-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key332518
ManufacturerBD OPHTHALMIC SYSTEMS
Manufacturer Address264 QUARRY ROAD MILFORD CT 06460 US
Baseline Brand NameK-3000 MICROKERATOME BLADE
Baseline Generic NameMICROKERATOME BLADE
Baseline Catalog No378607
Baseline Device FamilyBD K-3000 MICROKERATOME SYSTEM & ACCESSORIES
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]36
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK984537
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2001-07-18

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