HYDROXYAPATITE BIO-EYE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-05 for HYDROXYAPATITE BIO-EYE * manufactured by Integrated Orbital Implants.

Event Text Entries

[17107530] Pt in for enucleation of the right eye on 3/16/99. Physician requested 18mm implant, one was opened. Physician measured it and found to be 16mm. Then a 20mm was opened and it measured to be a 18mm (serial #49201, lot 605407). This implant was used for this pt. The actual size of the implant did not correlate with packaging info.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 217801
• MDR Report Key: 217801
• Date Received: 1999-04-05
• Date of Report: 1999-04-05
• Date of Event: 1999-03-16
• Date Facility Aware: 1999-03-16
• Report Date: 1999-04-05
• Date Reported to FDA: 1999-04-05
• Date Reported to Mfgr: 1999-04-05
• Date Added to Maude: 1999-04-08
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: HYDROXYAPATITE BIO-EYE
• Generic Name: OCULAR IMPLANT
• Product Code: HPZ
• Date Received: 1999-04-05
• Model Number: *
• Catalog Number: *
• Lot Number: 503412
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 211242
• Manufacturer: INTEGRATED ORBITAL IMPLANTS
• Manufacturer Address: 12526 HIGH BLUFF DRIVE SUITE 300 SAN DIEGO CA 92130 US

Device Sequence Number: 2

• Brand Name: HYDROXYAPATITE BIO-EYE
• Generic Name: OCULAR IMPLANT
• Product Code: HPZ
• Date Received: 1999-04-05
• Model Number: *
• Catalog Number: *
• Lot Number: 605407
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 211243
• Manufacturer: INTEGRATED ORBITAL IMPLANTS
• Manufacturer Address: 12526 HIGH BLUFF DRIVE SUITE 300 SAN DIEGO CA 92130 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-04-05