FDA Adverse Event Injury Summary report: N

FOCAL AND SPECIALLY PAN RETINAL PHOTOCOAGULATION LASER

MDR report key: 3642674 · Received February 19, 2014

Report

Report Number
MW5034623
Event Type
Injury
Date Received
February 19, 2014
Date of Event
December 16, 2013
Report Date
February 16, 2014
Product Code
HQF
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

RECENTLY I HAVE RETINAL EDEMA TO MY RIGHT EYE. THE BEST WAY TO TREAT PATIENTS IS THE USE OF NSAID DRUGS LIKE IBUPROFEN AS WELL AS TO MONITOR CLOSELY WITH SCANNING OF AFFECTED EYE 4-6 WEEKS INTERVAL THAT WILL CLEARLY TELL THE STATUS OF AFFECTED EYE INCLUDING INFLAMMATION, OTHERWISE VGF ANTIBODY INJECTION MIGHT HELP A LOT. SOMETIMES DEXAMETHASONE IMPLANT INJECTION IN THE EYE MIGHT HELP BUT I DOUBT SINCE LESS THAN 5% ARE BENEFITED. DOCTORS ALWAYS TRY TO INJECT FOR THEIR PERSONAL GAIN, NORMALLY THE FIRST INJECTION IS FREE BUT AFTER HEALTH INSURANCE DEDUCTIBLE, DOCTOR WILL INJECT SECOND ONE WITH DOUBLE COST THAT WILL COVER BOTH FIRST AND SECOND WITH SOME DISCOUNT ON THE GROUND THAT THE FIRST ONE CAN WORK FOR ONLY 2 AND A HALF MONTHS, THEY CAN MAKE GOOD MONEY FROM BOTH PATIENTS AND PHARMACEUTICAL COMPANY AND AT THE SAME TIME, PHARMACEUTICAL COMPANY CAN SELL THE INJECTION. THIS IS NOTING BUT MUTUAL GAME PLAN OF DOCTOR, PHARMACEUTICAL COMPANY AND THE COORDINATOR ON BEHALF OF INSTITUTE. ACTUALLY, IT IS A NATURAL HEALING PROCESS WHICH I REALIZED LATER AFTER A LOT OF RESEARCH. AS USUAL THE DOCTOR INJECTED DEXAMETHASONE/OZERDEX. ONCE I FOUND THAT I HAD INFLAMMATION, I ALSO TOOK 800 MG IBUPROFEN EVERY DAY SINCE I REALIZED THAT IS NOTHING BUT INFLAMMATION WHICH MIGHT STAY DUE TO COX2 ENZYME. NEXT, THE DOCTOR WANTED TO DO FOCAL AND PRP LASER TO MY RIGHT EYE. I REQUESTED HIM MANY TIMES WHY NOT WE WAIT AND SEE HOW IS THE PROGRESS BY USING SEVERAL PARAMETERS LIKE STATUS OF INFLAMMATION, HOW I CAN READ LETTERS AS WELL AS EYE PRESSURE. I TOLD HIM THAT IT CAN DAMAGE MY EYE SIGHT, EVEN IN SURGERY ROOM, I TOLD HIM TO WAIT AND TO WATCH. HE TOLD ME THAT HE CANNOT GIVE MY EYESIGHT BACK WHATEVER I LOST BUT LASER SURGERY IS ABSOLUTELY NECESSARY FOR PREVENTION FROM FURTHER DAMAGE, HE DID TWO LASER SURGERIES AND I LOST MY VISION. AT THIS MOMENT, I LOST MORE THAN 80% OF MY VISION, I CAN'T DRIVE WITH MY RIGHT EYE, I CAN'T SEE LANES, SIDE WALK BOUNDARIES, DIVIDERS ARE DISCONTINUED. I CAN'T READ BOOKS, HARD TO WRITE CHECKS, LETTERS ARE BROKEN AND MISSING. FOCAL LASER AND SPECIALLY PRP OR THEIR APPLICATION TECHNIQUE MADE MY RIGHT EYE ALMOST BLIND. WHEN I CLOSED MY EYES ONE AFTER ANOTHER TO COMPARE VISION CHECKS ON BOTH EYES, I CAN FEEL DARK IN MY RIGHT EYE, MOST OF THE LIGHT IS BLOCKED, IT SEEMS PRESENCE OF OPAQUE BARRIER IN FRONT OF MY EYE, MORE THAN 60% OF CORNEA'S TRANSPARENCY IS LOST, MORE THAN 60% OF CORNEA'S REFRACTION CAPACITY IS LOST, MOST LIKELY IT DENATURES COLLAGEN OR KILLED CELLS. CORNEA LOST ITS SIGNIFICANT TRANSPARENCY. PRP/APPLICATION TECHNIQUE USED KILLED MORE THAN 70% OF MY RETINA NERVE TISSUE RESULTING DISCONTINUITY OF CELLS WHICH SENSE A FRACTION OF LIGHT FROM THE OBJECT. SINCE A SIGNIFICANT NUMBER OF CORNEA TISSUE ARE DEAD BECAUSE OF LASER, LIGHT FROM ALL PARTS OF THE OBJECT CAN'T REACH TO MY CORNEA. AS A RESULT, NERVE SENDS INCOMPLETE IMPULSES THROUGH OPTIC NERVE BACK TO BRAIN WHICH TRANSLATE INCOMPLETE MESSAGES INTO INCOMPLETE IMAGES I SEE. THAT IS WHY I SEE BROKEN, DISCONTINUED/MISSING/UNABLE TO READ ANYTHING. THESE LASERS DESTROYED VESSELS IN RETINA AND CREATED LOCALIZED HIGHER EYE PRESSURE SINCE IT IS COMMON SENSE, VOLUME IS INVERSELY PROPORTIONAL TO PRESSURE. IF YOU KILL VESSELS, YOU ARE REDUCING VOLUME, AUTOMATICALLY IT WILL INCREASE EYE PRESSURE WHICH MIGHT TRIGGER GLAUCOMA IN FUTURE. THAT IS WHY MY PRESSURE JUMPS FROM 25 TO 34. THE IRONY IS THAT I TRUSTED HIM, IN RETURN HE MADE ME BLIND IN HIS OWN WAY OF GRATEFULNESS. I MIGHT NOT HAVE FACED THIS HORRIBLE SITUATION IF I DIDN'T TRUST HIM AND LEFT THAT DAY WITHOUT SURGERY OR HE MIGHT HAVE BEEN HONEST WITH ME AND NOT DONE THE LASER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
104242 FOCAL AND SPECIALLY PAN RETINAL PHOTOCOAGULATION LASER FOCAL AND SPECIALLY PAN RETINAL PHOTOCOAGULATION LASER HQF

Patients

Seq Age Sex Outcome Treatment
1 59 YR Hospitalization| O| R| S