FDA Adverse Event Injury Summary report: N

EXCIMER LASER

MDR report key: 7240946 · Received February 2, 2018

Report

Report Number
MW5075049
Event Type
Injury
Date Received
February 2, 2018
Date of Event
October 14, 2015
Report Date
February 1, 2018
Manufacturer
ABBOTT MEDICAL OPTICS INC. (AMO)
Product Code
LZS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN (B)(6) 2015 I HAD LASIK SURGERY ON BOTH EYES. MY COMPLAINT BEGINS WITH A GROSSLY IMPROPER AND INCOMPLETE "INFORMED CONSENT" PROCESS INITIALLY BY THE AUXILIARY STAFF. IT WAS COMPOUNDED LATER BY THE DOCTORS EXTREME CAVALIER ATTITUDE TOWARDS MY CONCERNS, QUESTIONS AND EXPECTATIONS OF LASIK TREATMENT. THIS MISINFORMATION AND LACK OF INFORMATION IS THE CRUX OF MY COMPLAINT WITH MY PROCEDURE. MY INITIAL LASIK CONSULTATION WAS WITH A SCREENING TEAM AND CONSISTED OF EXAMS DONE WITH VARIOUS DEVICES WHICH PROVIDE THE DOCTOR WITH INFORMATION NECESSARY TO DO THE PROCEDURE. LATER I WAS PLACED IN A ROOM BY MYSELF WITH AN (B)(6) TO VIEW A GENERIC INFOMERCIAL ABOUT THE TYPES OF LASIK PROCEDURES THAT ARE AVAILABLE AND THE BENEFITS AND COMPLICATIONS ASSOCIATED WITH EACH. AGAIN, NO INFORMATION WAS TARGETED SPECIFICALLY FOR ME. AFTERWARDS AN ASSISTANT ASKED IF I HAD ANY QUESTIONS AND SHE REPEATED SOME OF THE INFORMATION FROM THE PRESENTATION. SHE WAS NOT ABLE TO TELL ME WHICH PROCEDURE WAS APPROPRIATE FOR MY NEEDS AND SAID THAT SHOULD BE DISCUSSED WITH THE DOCTOR. SO THE PATIENT LEAVES WITH ONLY GENERAL LASIK INFORMATION AND NOTHING THAT PERTAINS SPECIFICALLY TO THEM. WEEKS LATER DURING MY EXAM WITH THE DOCTOR, HE MENTIONED 2 LASIK OPTIONS FOR ME BUT IMMEDIATELY TOOK THE MONOVISION OPTION OFF THE TABLE. HE THEN DESCRIBED AN OPTION WHICH WOULD CORRECT MY DISTANCE VISION IN BOTH EYES BUT I WOULD NEED READERS FOR NEAR VISION. WHEN I ASKED WHY THAT WAS, HE ANSWERED THAT I HAVE PRESBYOPIA AND LASIK CANNOT CORRECT PRESBYOPIA. (MISREPRESENTATION). HE DID NOT SAY THAT LASIK CANNOT CORRECT BOTH NEAR AND DISTANCE IN THE SAME EYE (LACK OF CRITICAL INFORMATION). THE MANNER IN WHICH HE DESCRIBED THE PROCEDURE AND OUTCOME LEFT ME TO BELIEVE THAT MY DISTANCE VISION WOULD BE PERFECT AND MY NEAR VISION WOULD BE BETTER THAN PRE-SURGICAL BUT NOT PERFECT. COMMON POSSIBLE COMPLICATIONS ASSOCIATED WITH LASIK TREATMENT WERE DISCUSSED AND ALSO HOW THOSE COMPLICATIONS ARE TYPICALLY MANAGED. A CONSENT FORM WAS EMAILED TO ME A FEW DAYS BEFORE SURGERY. IN THE BODY OF THE CONSENT FORM, THERE IS NO MENTION THAT NEAR AND DISTANCE VISION CANNOT BE CORRECTED IN THE SAME EYE. ONE OF THE LAST PAGES OF THE CONSENT FORM IS AN ADDENDUM. THE HEADER OF THE ADDENDUM IS "IF YOU ARE OVER 40 AND ARE HAVING YOUR DISTANCE VISION ONLY CORRECTED, THERE WILL BE AN ADVERSE AFFECT TO YOUR NEAR VISION. THE PROBLEM IS THE ADDENDUM STARTS WITH, "IF YOU HAVING YOUR DISTANCE VISION ONLY CORRECTED..." FROM MY PERSPECTIVE, I WASN'T AWARE THIS WAS MY SITUATION. I HAD NO IDEA THE DOCTOR PLANNED TO CORRECT ONLY MY DISTANCE VISION. THERE IS NO MENTION THAT A LIMITATION OF LASIK IS THAT NEAR AND DISTANCE VISION CANNOT BE CORRECTED IN THE SAME EYE. THIS IS IMPORTANT AND SHOULD HAVE BEEN PROMINENTLY DISPLAYED IN THE GENERIC INFOMERCIAL THE PATIENT VIEWS ON THE (B)(6) IN THE PROMOTIONAL MATERIAL PROVIDED BY THE LASIK COMPANIES AND ON DISPLAY IN DOCTORS OFFICES, IT STATES THAT LASIK CORRECTS NEAR VISION, DISTANCE VISION AND ASTIGMATISM... THAT MATERIAL FAILS TO STATE THAT IT CANNOT BE ALL DONE AT THE SAME TIME IN THE SAME EYE! ON THE DAY OF SURGERY THE DOCTOR SAID REPEATEDLY, YOU WILL HAVE TO WEAR READERS FOR NEAR VISION AFTER SURGERY. I THOUGHT HE WAS COVERING HIS TAIL MAKING SURE I KNEW MY NEAR VISION WOULD BE IMPROVED BUT NOT PERFECT. I HAD NO IDEA HE WAS ABOUT TO MAKE MY NEAR VISION WORSE. AFTER SURGERY WHEN I ASKED WHY HE DIDN'T TELL ME MY NEAR VISION WOULD BE WORSE, HE SAID "I TOLD YOU YOU WOULD NEED READERS AND THAT'S THE SAME THING". INFORMED CONSENT! A STANDARDIZED LASIK CONSENT FORM SHOULD BE CREATED AND BE MADE MANDATORY. INFORMED CONSENT IS KEY! THE EXTREME DISREGARD FOR INFORMED CONSENT IS INEXCUSABLE. THERE'S MORE BUT IT WILL NOT FIT IN 4000 WORDS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
82455 EXCIMER LASER EXCIMER LASER SYSTEM LZS ABBOTT MEDICAL OPTICS INC. (AMO)

Patients

Seq Age Sex Outcome Treatment
1 58 YR