BAUSCH AND LOMB STORZ ANTERIOR CHAMBER NEEDLE
Received Jun 5, 2009 · Event occurred May 27, 2009
Report MW5011377 · MDR key 1400301
Device
Product problems
- Device, or device fragments remain in patient
- Metal Shedding Debris
Patient
16 YR
- Nonresorbable materials, unretrieved in body
- Foreign body, removal of
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
PATIENT HAD A PHACOEMULSIFICATION AND IMPLANTATION FOR A 26.0 DIOPTER LENS IN THE RIGHT EYE FOR A POSTERIOR SUBCAPSULAR CATARACT OF THE RIGHT EYE. FOLLOWING INSERTION OF THE PCIOL AND IRRIGATION OF THE WOUND VIA CANNULA, THE PHYSICIAN NOTED QUESTIONABLE MATERIAL IN THE RIGHT EYE. PHYSICIAN NOTES THE QUESTIONABLE MATERIAL TO BE SHINY FRAGMENTS. AFTER REPEATED IRRIGATION AND ASPIRATIONS OF THE WOUND, ONLY 2 EXTREMELY TINY FRAGMENTS WERE FOUND ATTACHED TO ELEMENTS THAT COULD NOT BE REMOVED. AN ORBITAL XRAY OF THE RIGHT EYE WAS NEGATIVE. POSTOPERATIVE FOLLOWUP FINDS THE PATIENT'S VISION TO BE 20/20 AND FRAGMENTS ARE NO LONGER VISIBLE.