InjuryMSR
BASIC VENTURI PHACO PACK
Received Mar 20, 2006 · Event occurred Feb 8, 2006
Report 1920664-2006-00015 · MDR key 689918
Device
Generic name
Opththalmic Microsurgical Assessory Pack
Manufacturer
Bausch & Lomb, Inc.Model number
NACatalog number
DP4305E
Lot number
NA
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Rupture due to stress from capsular contracture
- Eye Burn
Narrative
Description of Event or Problem
DURING A POSTERIOR POLAR CATARACT EXTRACTION PROCEDURE, A LOSS OF ASPIRATION THROUGH THIS BASIC VENTURI PACK RESULTED IN A CORNEAL BURN TO THE PT. ADDITIONALLY, AN IRIS PROLAPSE OCCURRED, THE POSTERIOR OR CAPSULE RUPTURED AND A CATARACT FRAGMENT WAS LOST INTO THE VITREOUS. STUCHES WERE REQUIRED TO CLOSE THE WOUND.