InjuryHMT
CUSTOM PAK
Received Oct 30, 2008 · Event occurred Sep 24, 2008
Report 1644019-2008-00032 · MDR key 1216654
Device
Generic name
Convenience Kit
Manufacturer
Alcon - HoustonModel number
CUSTOM PAKCatalog number
CUSTOM PAK
Lot number
830731H
Product problems
- Foreign material
Patient
NI
- Foreign body, removal of
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY HAD A FIBER IN THE EYE ON THE EVENT DATE, FOUND DURING POST OP VISIT THE FOLLOWING DAY, AND THE SECOND SURGERY WAS IN 2008, TO REMOVE THE FIBER. THE FIBER WAS WHITE WITH BLUE TINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 10/30/2008.
Remedial action
- Other