PROCLEAR TORIC

Report

Report Number: 1118577-2008-00001
Event Type: Injury
Date Received: July 2, 2008
Date of Event: January 2, 2006
Report Date: June 3, 2008
Manufacturer: COOPERVISION, INC.
Product Code: LPL
PMA / PMN Number: K970095
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

LENS FROM THE SAME LOT AS ACTUAL DEVICE WAS EXAMINED. BASED CURVE, DIAMETER, OSMOLARITY/PH AND VISUAL INSPECTION TESTS PERFORMED. SURFACE WAS GOOD AND ALL MEASUREMENTS WERE WITHIN MFG SPECS. CORNEAL SCARRING COULD BE CAUSED BY ANY NUMBER OF KNOWN ADVERSE REACTIONS THAT ARE LISTED IN THE PACKAGE INSERT FOR THE DEVICE, I.E. "INFECTION, ABRASION, CORNEAL ULCER..." ETC. BASED ON THE PT'S HISTORY AS REPORTED BY A DIFFERENT EYECARE CLINICS, THE PT WAS CONTRAINDICATED FOR CONTACT LENS WEAR AS LISTED IN THE PACKAGE INSERT FOR THE DEVICE, I.E. "ANY EYE DISEASE, INJURY, OR ABNORMALITY THAT AFFECTS THE CORNEAL CONJUNCTIVE, OR EYELIDS." PT'S BEST VA BEFORE AND AFTER THE EVENT IS 20/25 IN BOTH EYES. THIS CASE IS CONSIDERED TO BE POSSIBLE PERMANENT SCARRING OF THE CORNEA. THE PT'S HISTORY INDICATES SCARRING TO BE PRESENT AS FAR AS (B)(6) 2006, WHEN PT WAS WEARING ANOTHER BRAND OF LENSES. SINCE THAT TIME, PT HAS WORN 5 DIFFERENT BRANDS OF LENSES. ALTHOUGH THE CAUSE OF THE EVENT IS NOT KNOWN, THE TREATING PHYSICIAN INDICATES THE CAUSAL RELATIONSHIP TO THE LENS CANNOT BE RULED OUT. BASED ON INFO PROVIDED TO DATE, THERE IS NO CLEAR INDICATION THAT THE PT'S CONDITION WAS CAUSED BY THE SUBJECT LENSES.

Description of Event or Problem · 1

PT COMPLAINS OF CORNEAL SCARRING DUE TO CONTACT LENS WEAR. EYECARE PHYSICIAN CONFIRMED ELEVATED CORNEAL SCARS AND DEVELOPMENT OF INFILTRATE. ECONOPRED QID PRESCRIBED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROCLEAR TORIC	OMAFILCON A TORIC SOFT CONTACT LENS	LPL	COOPERVISION, INC.		200718094L

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR		Disability	OPTIVE OPHT EYEDROPS