STORZ DECEMET KELLY MEMBRANE PUNCH
Received Apr 11, 2012 · Event occurred Feb 28, 2012
Report 1920664-2012-00060 · MDR key 2542964
Device
Generic name
Decemet Kelly Membrane Punch
Manufacturer
Bausch & Lomb, Inc.Model number
E2798Catalog number
E2798
Product problems
- Break
Patient
87 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
A REPORT FROM THE USER FACILITY REPORTED "AN (B)(6) FEMALE UNDERWENT A TRABECULECTOMY WITH MITOMYCIN-C TO HER RIGHT EYE AND PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATION WITH THE USE OF MALYUGIN IN THE RIGHT EYE ON (B)(6) 2012. INTRAOPERATIVELY, THE KELLY PUNCH BROKE AT 2.5 MM OF THE TIP FRAGMENT WAS RETRIEVED FROM THE PT'S RIGHT EYE FLAP". THE PT WAS DISCHARGED FROM THE HOSPITAL; HOWEVER, THE PT'S OUTCOME, THOUGH REQUESTED, HAS NOT BEEN SUPPLIED BY THE USER FACILITY TO BAUSCH & LOMB.
Additional Manufacturer Narrative
THE USER FACILITY REPORTED VIA VOLUNTARY REPORT (B)(4). THE USER FACILITY REPORTED THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED, SHOULD ADDITIONAL INFORMATION BE RECEIVED OR THE DEVICE BECOME AVAILABLE FOR INVESTIGATION. CORRECTION TO VOLUNTARY USER FACILITY REPORT: (B)(4). THE KELLY PUNCH WAS IDENTIFIED AS SERIAL NUMBER (B)(4); HOWEVER, THE NUMBER DOES NOT CORRESPOND TO BAUSCH & LOMB KELLY PUNCH INSTRUMENTS. THE CORRECT NUMBER HAS BEEN PROVIDED IN THIS REPORT.