IOWA PK PRESS PUNCH

Description of Event or Problem

A REPORT FROM A USER FACILITY IN THE (B)(4) WAS RECEIVED STATING: "DEFECTIVE. MISSING THE 2 TIERS OF THE PUNCH, WHICH WASN'T DISCOVERED UNTIL THEY WERE IN THE MIDDLE OF THE CORNEAL TRANSPLANT, WHICH WAS ABORTED." ADDITIONAL INFORMATION RECEIVED (B)(6) 2011 STATES "THE PATIENT HAD RECEIVED STANDARD SEDATION FENTANYL AND VERSED IVP (MAC) ONLY. THE E3054 PUNCH HAS 3 TIERS TO SLIDE THE TREPHINES INTO. THEY PLACED TREPHINE ON TOP OF PUNCH AND THE BOTTOM WAS GONE. THE DOCTOR HAD MADE A SLIGHT INCISION IN THE PATIENT'S EYE AND STITCHED THE INCISION. THE PATIENT WAS DISCHARGED HOME AFTER RECOVERING FROM SEDATION AND WILL FOLLOW UP WITH DR. (B)(6) TO RESCHEDULE PROCEDURE."

Additional Manufacturer Narrative

VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED ONE E3054 PRESS PUNCH WAS RETURNED WITH THE CENTRAL PLATFORM (BASE), ONE SPRING ACTIVATED AND REMOVABLE PISTON AND TWO TEFLON BLOCKS WITH RED CENTERS. THE ORIGINAL PACKAGING WAS NOT RETURNED. INSPECTION OF THE ASSEMBLY VERIFIED THAT THE COMPONENTS WERE ALL PRESENT AND ASSEMBLED CORRECTLY. THE CUSTOMER WAS NOTIFIED OF THE EVALUATION AND SUBSEQUENTLY THE CUSTOMER WAS PROVIDED INSTRUCTION ON THE ASSEMBLY DESIGN. THE CUSTOMER REPORTED THAT UNDERSTANDING THE DESIGN RESULTED IN SATISFACTION WITH THE DEVICE PERFORMANCE.