SOFTCON EW

MDR report key: 106236 · Received July 18, 1997

Report

Report Number: 1030321-1997-00006
Event Type: Injury
Date Received: July 18, 1997
Date of Event: December 2, 1996
Report Date: July 18, 1997
Manufacturer: CIBA VISION CORP.
Product Code: LPM
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

TWO LENSES WERE RETURNED AND INVESTIGATED AFTER MDR REPORTED TO FDA. HOWEVER, LOT NUMBER WAS STILL UNAVAILABLE.

Description of Event or Problem · 1

SERIOUS INJURY INVOLVING ONE PERSON ON 12/2/96, CONSUMER WENT TO HER DOCTOR BECAUSE OF AN INFLAMED LEFT EYE. DOCTOR DIAGNOSED CORNEAL ULCER AND ADMINISTERED CILOXAN AND STEROID DROPS. LENS MODEL/WATER CONTENT: SOFTCON EW, 55%: LOT NUMBER: UNK; EYE INVOLVED: LEFT, 84/140/-175; REFRACTION: MYOPIA; TOTAL DURATION OF USE (IN MONTHS): 10: NUMBER OF DAYS LENS WORN: 1; LAST VISIT TO DOCTOR PRIOR TO SYMPTOMS: 2/18/95; TYPE OF LENS CARE SYSTEM USED: CHEMICAL; DISINFECTION SYSTEM USED: COMPLETE; HOMEMADE SALINE USED: NO: DAYS LENS WORN BETWEEN CLEANING AND DISINFECTING: 1; DAYS LENS WORN BETWEEN CLEANING AND SYMPTOMS: 1: DAYS BETWEEN SYMPTOMS AND CALLING DOCTOR: 1: SELF-TREATMENT BY PT: NO: HAND WASHING BEFORE LENS MANIPULATION: YES; ULCER LOCATION: 11 O'CLOCK; VISUAL ACUITY BEFORE SYMPTOMS: UNK; VISUAL ACUITY AFTER SYMPTOMS: 20/25; RESULTS OF CULTURE: NONE TAKE: RESULTS OF CORNEAL BIOPSY AND/OR SCRAPINGS: NONE TAKEN; DIAGNOSIS: CORNEAL ULCER; TREATMENT ADMINISTERED: CILOXAN AND STEROID DROPS:

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SOFTCON EW	SOFT CONTACT LENS	LPM	CIBA VISION CORP.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Other