FDA Adverse Event Injury Summary report: N

PHACOFRAGMENTATION UNIT

MDR report key: 6435787 · Received March 22, 2017

Report

Report Number
MW5068661
Event Type
Injury
Date Received
March 22, 2017
Date of Event
March 12, 2016
Report Date
March 22, 2017
Manufacturer
ALCON RESEARCH LTD.
Product Code
HQC
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2016 I HAD A RIGHT EYE CATARACT SURGERY AT (B)(6). I HAD EVERY REASON TO BELIEVE I WAS SAFE AND THAT THE OPERATION WOULD BE A SUCCESS. JUST THE OPPOSITE IS TRUE. DURING THE PROCEDURE I WAS COMPLETELY COGNIZANT: COULD HEAR, FEEL AND SEE. THEY CAN NOT ALLOW YOU TO SLEEP BECAUSE OF REM. THE DOCTOR WAS TO MIGHT RIGHT, SOON AFTER THE PROCEDURE BEGAN SHE STATED OUT LOUD, "HMM THAT HAS NEVER HAPPENED BEFORE". RATHER THAN PANIC, I WANTED THE BEST OF HER PROFICIENCY AND KNOWLEDGE TO DO WHAT EVER NEEDED TO BE DONE IN WHAT EVER WAS HAPPENING TO ME ON THE OPERATING ROOM TABLE. WHEN I WENT INTO THE RECOVERY ROOM, ASKED FOR THE OPHTHALMOLOGIST I WANTED TO SPEAK TO HER AND ASK HER WHAT HAD HAPPENED. SHE ALREADY HAD LEFT, BUT HAD AN APPOINTMENT THE VERY NEXT DAY ((B)(6) 2016). MY HUSBAND AND I ENTERED THE EXAM ROOM AND THE FIRST QUESTION I ASKED WAS "WHAT WENT WRONG IN THE OPERATING ROOM?", SHE EXPLAINED THAT A TOOL SHE WAS USING BROKE ON MY EYE DURING THE PROCEDURE. MY HUSBAND AND I QUESTIONED HER ABOUT WERE THERE ANY SHARDS, WOUND, ANYTHING THAT WOULD CAUSE ME TO MEDICALLY HAVE PROBLEMS. SHE SAID NO. A WEEK LATER I REQUESTED THE RECORDS OF BOTH (B)(6) AND DR. (B)(6) RECORDS, NEITHER REPORT EVEN MENTIONED THAT A TOOL BROKE DURING THE SURGERY. I AGAIN RETURNED TO HER OFFICE AND SHE SAID IT DIDN'T BEAR REPORTING BECAUSE EVERYTHING WAS ALL RIGHT. THE SURGERY CENTER DID NOT HAVE ANY MENTION OF THIS IN THE RECORDS THEY HAD. WHEN I TOLD THE ADMINISTRATOR OF THE SURGERY CENTER, SHE HAD NO KNOWLEDGE OF ANYTHING LIKE THAT HAPPENING. MY SYMPTOMS FROM THIS SURGERY ARE: STAGGERING, CANNOT WALK IN A STRAIGHT LINE, RELY ON MY HUSBAND TO GUIDE ME ANYWHERE WE GO IN WALKING, DIZZINESS, NAUSEA, FALLING, UNSURE STEP. I HAVE BEEN TO: NEUROLOGISTS, ENT SPECIALISTS, NEUROLOGICAL OPHTHALMOLOGIST, ALL OF THEM CANNOT EXPLAIN MY SYMPTOMS. WHAT IS DETERMINED IS ONE EYE LOOKS UP SLIGHTLY AND THE OTHER DOWN SLIGHTLY. WHAT HAPPENED TO THE TOOL? SOMEONE MUST HAVE BEEN RESPONSIBLE TO CHECK TOOLS AFTER EACH OPERATION. WHY DIDN'T THEY REPORT IT TO THE SURGERY CENTER WHEN IT WAS FOUND. WHY DIDN'T THE DOCTOR REPORT THE TOOL BROKE DURING THE PROCEDURE, THAT IN MY OPINION IS FRAUDULENT, IRRESPONSIBLE, UNCARING FOR HER PROFESSIONAL LEVEL AND FOR HER PATIENT. WHAT HAPPENED TO THE TOOL USED ON ME, HOW MANY TIMES DOES THAT OCCUR THAT A TOOL BREAKS ON A PERSON'S EYE? WHY WASN'T THIS DISCOVERED AT ANY TIME AFTER THE OPERATION AND REPORTED. I HAVE REPORTED THIS TO THE (B)(6), WRITTEN GRIEVANCES TO THE SURGERY CENTER AND THE OPHTHALMOLOGIST, AS WELL AS ALL OF THE DOCTORS WHO HAVE A FINANCIAL INTEREST IN (B)(6) MAKING THEM APPRISED OF WHAT HAPPENED. I HAVE ASKED FOR A LIST OF TOOLS THAT WERE USED IN ME, A PRINTED LIST WAS GIVEN TO ME, BUT NONE SEEM TO BE ABLE TO EXPLAIN WHICH WAS USED DURING THE PROCEDURE. I AM AT A LOSS TO FIND OR EVEN UNDERSTAND A BROKEN TOOL. AND THEN NOT SEEMINGLY BEING A CONCERN FOR THE PATIENT, FUTURE PATIENTS, PROCEDURES IN THEIR FACILITY. PLEASE HELP ME. I NEED DIRECTION AND SOMEONE TO STEP FORWARD AND FIND OUT THE TRUTH OF ALL OF THIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
208993 PHACOFRAGMENTATION UNIT PHACOFRAGMENTATION UNIT HQC ALCON RESEARCH LTD.

Patients

Seq Age Sex Outcome Treatment
1 76 YR Other| S ASPIRIN| B COMPLEX| BACLOFEN| CRANBERRY| IBP 800| KELP| MAGNESIUM| OTC MEDS: A AND D| RX MEDS: PROAFERONE