NEW VUES
Received May 18, 1998 · Event occurred Apr 20, 1998
Report 9681121-1998-00010 · MDR key 167747
Device
Generic name
Disposable Soft Contact Lens
Manufacturer
P.t. Ciba Vision BatamModel number
NACatalog number
NA
Lot number
8423015
Patient
UNKNOWN
Narrative
Description of Event or Problem
SERIOUS INJURY INVOLVING ONE PERSON. ON 4/20, PT REPORTED TO HIS DR COMPLAINING OF TEARING, PAIN, AND PHOTOPHOBIA IN RIGHT EYE, LENS MODEL/WATER CONTENT: NEWVUES/55%; LOT #8423015; EYE INVOLVED: RIGHT: REFRACTION: MYOPIA; DURATION OF USE (MONTHS) WEARING MODALITY; TRIAL LENS PERIOD/NO REPORT OF DISPENSE DATE; NUMBER OF DAYS LENS WORN: UNK; LAST VISIT TO PRACTITIONER PRIOR TO SYMPTOMS: UNK; TYPE OF LENS CARE SYTEM USED: UNK; DISINFECTING SYSTEM USED: UNK; WAS HOMEMADE SALINE USED:NO; NUMBER OF DAYS WORN BETWEEN CLEANING AND DISINFECTING: UNK; DAYS BETWEEN CLEANING AND SYMPTOMS: UNK; DAYS BETWEEN SYMPTOMS AND CALLING DR: SAME DAY; SELF-TREATMENT BY PT: UNK; HAND WASHING BEFORE LENS MANIPULATION: UNK; ULCER LOCATION: UNK; VISUAL ACUITY BEFORE SYMPTOMS: UNK; VISUAL ACUITY AFTER SYMPTOMS: UNK; RESULTS OF CULTURE: NOT REPORTED; RESULTS OF CORNEAL BIOPSY AND/OR SCRAPINGS: UNK; CLINICAL DIAGNOSIS: PT REPORTS CORNEAL ULCER; TREATMENT ADMINISTERED: UNK; PROGNOSIS: PT STATES CONDITION IMPROVING WITH FOLLOW-UP SCHEDULED 5/07/98.