FDA Adverse Event Injury Summary report: N

VISX

MDR report key: 221333 · Received April 28, 1999

Report

Report Number
1221842-1999-00001
Event Type
Injury
Date Received
April 28, 1999
Date of Event
March 29, 1999
Report Date
April 28, 1999
Manufacturer
VISX, INC.
Product Code
GEX
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PT HAS NO SIGNIFICANT MEDICAL HISTORY WITH NO KNOWN ALLERGIES AND WAS NOT ON ANY MEDICATION. PT HAD HISTORY OF WEARING CONTACT LENS BUT DISCONTINUED 1 YEAR AGO. ON 3/24/99, PT UNDERWENT UNCOMPLICATED "PRK" (LASER TRANSEPITHELIAL ABLATION WITH 45 UM OF EPITHELIUM REMOVAL AND 40 UM OF STROMAL TISSUE REMOVAL). POSTOPERATIVELY, PT WAS WEARING PRECISION CONTACT LENS (CL) IMMEDIATELY AFTER PRK. PT RETURNED FOR REGULAR FOLLOW-UP ON 3.25 AND 3/26. ON 3/26/99, PT'S VISION IMPROVED TO 20/100 WITHOUT CORRECTION. THE EXAMINATION DEMONSTRATED A SMALLER HEALING EPITHELIUM DEFECT (1X3 MM) WITH CL ON. PT WAS INSTRUCTED TO CONTINUE USING CILOXAN AND VEXOL 4 TIMES A DAY CL. PT WAS OUT OF TOWN FROM 3/26 TO 3/28/99. HOWEVER, PT NOTICED SOME VISION CHANGE SINCE 3/27/99. PHYSICIAN WAS NOT NOTIFIED ABOUT THE SYMPTOMS. ON 3/29/99, PT RETURNED TO CLINIC, EXAMINATION SHOWED 6 MM EPITHELIAL DEFECT WITH DIFFUSE SUPERFICIAL STROMAL CELLULAR INFILTRATION UNDER THE EPITHELIAL DEFECT AREA. THERE WAS NO SIGN OF CONJUNCITIVAL INJECTION OR DISCHARGE. ANTERIOR CHAMBER WAS DEEP AND QUIET. BECAUSE THE RELATIVELY EXCESSIVE MOVEMENT OF THE CONTACT LENS, A NEW PRECISION CL WAS REPLACED. PT WAS THEN INSTRUCTED TO INCREASE VEXOL AND CILOXAN EVERY HR IMMEDIATELY. AT 3 PM, PT'S CL FELL OUT ON HER CHEEK AND PT ALSO NOTICED MORE FOREIGN BODY SENSATION AND VISION CHANGE. PT WAS IMMEDIATELY REEXAMINED AT 3.30 PM. ON EXAMINATION, PT'S RIGHT INFERIOR CORNEA MELTED WITH 3 MM OF PERFORATION AND FLAT ANTERIOR CHAMBER. PT DENIED ANY TRAUMA OR USING ANY ANESTHETICS SINCE PRK PROCEDURE. THE PREFORATED CORNEA WAS IMMEDIATELY GLUED WITH TISSUE GLUE AND LARGER CONTACT LENS PLACED. ON 3/30/99, PT'S ANTERIOR CHAMBER REMAINED SHALLOW AND CORNEA TRANSPLANT PERFORMED ON 3/30/99.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VISX EXCIMER LASER GEX VISX, INC. MODEL C NA

Patients

Seq Age Sex Outcome Treatment
1 27 YR Other