BIO-EYE I00020S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-02 for BIO-EYE I00020S manufactured by Integrated Orbital Implants, Inc..

Event Text Entries

[16502096] Exposures are an anticipated possible complication with this type of surgery. A review of the literature finds exposure rates ranging from 2. 5% to 21. 6%. Discussion of these cases with the reporting physician suggests a correlation with changes in the clinic's wrapping practices. It is unknown whether there is a causal relationship. We are anticipating the return of the explanted devices for further investigation.
Patient Sequence No: 1, Text Type: N, H10


[16704543] Physician's office reported that the doctor implanted a 20mm sterile implant. The pt now has an "exposed" implant. Pt returned to surgery for removal of implant in 2007.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027377-2007-00008
MDR Report Key974754
Report Source05
Date Received2008-01-02
Date of Report2007-12-13
Date of Event2007-12-14
Date Mfgr Received2007-12-13
Device Manufacturer Date2007-04-01
Date Added to Maude2008-01-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactNATALIE KENNEL, CONSULTANT
Manufacturer Phone8582594355
Manufacturer G1INTEGRATED ORBITAL IMPLANTS, INC.
Manufacturer Street12625 HIGH BLUFF DRIVE
Manufacturer CitySAN DIEGO CA 92130
Manufacturer CountryUS
Manufacturer Postal Code92130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIO-EYE
Generic NameIMPLANT, EYE SPHERE
Product CodeHPZ
Date Received2008-01-02
Model NumberI00020S
Catalog NumberI00020S
Lot Number198037
Device Expiration Date2013-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedV
Device Sequence No1
Device Event Key943409
ManufacturerINTEGRATED ORBITAL IMPLANTS, INC.
Manufacturer AddressSAN DIEGO CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2008-01-02

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