CHANG PHACO CHOPPER

Additional Manufacturer Narrative

RECEIVED PAGE 1 ONLY OF USER FACILITY VOLUNTARY REPORT (FORM 3500) DATED (B) (4) 2010 VIA POSTAL SERVICE ON 03/25/2010. OF USER FACILITY VOLUNTARY REPORT (3500) INDICATED DEVICE AVAILABLE FOR EVALUATION. MANUFACTURER CONTACTED THE USER FACILITY ON SEVERAL OCCASIONS, LEFT MESSAGES FOR THE RISK MANAGER, AND USER FACILITY NEVER RETURNED CALLS OR FORWARDED THE SUBJECT DEVICE FOR MANUFACTURER'S EVALUATION. WITHOUT HAVING THE ACTUAL SUBJECT DEVICE AVAILABLE FOR EVALUATION, OR THE ABILITY TO DISCUSS THE EVENT WITH THE USER FACILITY AND/OR USER; THE MANUFACTURERS EVALUATION WAS LIMITED TO THE REVIEW OF THE SAME DEVICE CURRENTLY HELD IN THE MANUFACTURER'S CONTROLLED FINISHED GOODS INVENTORY AND A REVIEW OF THE DEVICE HISTORY RECORDS AND FIELD USE HISTORY. MAGNIFIED VISUAL EXAMINATION OF DEVICES IN THE MANUFACTURERS CONTROLLED INVENTORY, FOUND NO ANOMALIES AND CONFIRMED ALL UNITS ARE WITHIN SPECIFIED TOLERANCES. DEVICE HISTORY RECORDS WERE ALSO CONFIRMED TO BE IN ORDER NO ANOMALIES. BASED ON THIS, NO FINAL CONCLUSIONS CAN BE DRAWN CONCERNING THE REPORTED EVENT. (B) (4). (B) (4). THE REPORTER DOES WANT THEIR IDENTITY DISCLOSED.

Description of Event or Problem

USER FACILITY VOLUNTARY REPORT DATED (B) (4) 2010; STATED: "DURING CATARACT PROCEDURE ON RIGHT EYE, THE PHYSICIAN NOTICED THE MICROTIP OF THE PHACO CHOPPER MISSING. THE RIGHT EYE WAS IRRIGATED CONTINUOUSLY AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN WAS UNABLE TO VISUALIZE THE TIP WITH OPHTHALMOSCOPE. AN X-RAY WAS DONE AND THE TIP WAS NOT SEEN."