CLEAR CARE CLEANING AND DISINFECTANT

MDR report key: 2067945 · Received April 20, 2011

Report

Report Number: 8020392-2011-00006
Event Type: Injury
Date Received: April 20, 2011
Date of Event: February 9, 2011
Report Date: March 22, 2011
Manufacturer: CIBA VISION CANADA, INC.
Product Code: LPN
PMA / PMN Number: K030522
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT A CONSUMER EXPERIENCED A CORNEAL BURN, A CORNEAL ULCER, CONJUNCTIVAL REDNESS AND PHOTOPHOBIA, RIGHT EYE ASSOCIATED WITH AOSEPT PLUS/CLEAR CARE LENS CARE SOLUTION. THE ANTERIOR CHAMBER WAS NORMAL (NO CELL OR FLARE). VISUAL ACUITY ON THE EXAM DATE WAS (B)(6) (20/200) RIGHT EYE. TREATMENT CONSISTED OF TOBREX OPHTHALMIC DROPS 2 DROPS THREE TIMES A DAY (DURING 5 DAYS), EURONAC 2 DROPS FOUR TIMES A DAY (DURING 5 DAYS), DEXPANTHENOL GEL 2 DROPS IN THE EVENING BEFORE SLEEPING FOR 4 DAYS AND LACRIFLUID 1 TO 2 DROPS AS NEEDED DURING ONE MONTH. A PHOTO OF THE CONSUMER WAS PROVIDED WHICH SHOWED SHE WAS WEARING AN EYE PATCH (NO INDICATION OF PRESSURE OR NON PRESSURE). PATCHING IS GENERALLY CONTRAINDICATED FOR AN ULCERATIVE EVENT OR IN ANY EVENT THAT MIGHT BE SUSPECTED INFECTIOUS. FOLLOW VISIT FIVE DAYS LATER INDICATED SLIGHT SUPERFICIAL PUNCTATE KERATITIS ("KPS") REMAINED. F/U INFO RECEIVED (B)(6) 2011 INDICATED THAT NO FURTHER OFFICE VISITS WERE NECESSARY BECAUSE THE CICATRIZATION IS OK, THERE IS NO SCAR, AND THE KPS REMAINED WAS TEMPORARY AND NOT SERIOUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CLEAR CARE CLEANING AND DISINFECTANT	LENS ACCESSORIES	LPN	CIBA VISION CANADA, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention