FDA Adverse Event Injury Summary report: N

DAILIES FRESHLOOK ILLUMINATE

MDR report key: 2693049 · Received August 9, 2012

Report

Report Number: 9610813-2012-00011
Event Type: Injury
Date Received: August 9, 2012
Report Date: July 10, 2012
Manufacturer: CIBA VISION GMBH
Product Code: MVN
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVAL. RETAINED PRODUCT FROM THE SAME LOT WAS EVALUATED AND ALL TESTING WAS FOUND TO BE WITHIN SPECIFICATION. THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT FRESHLOOK ONE-DAY THAT IS SOLD IN THE UNITED STATES UNDER PMA/510 (K) # K050213. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED BY A PT THAT SHE EXPERIENCED PAIN IN HER LEFT EYE FOLLOWING THREE HOURS OF CONTACT LENS WEAR. SHE REMOVED THE LENS AND OBSERVED AN EDGE TEAR ON THE LENS. THE PT REPORTED ANOTHER LENS THAT TORE IN TWO PLACES DURING WEAR. THE PT REPORTED THAT SHE WAS DIAGNOSED WITH A NON-INFECTIOUS CORNEAL ULCER AND TREATED WITH TWO DIFFERENT ANTIBIOTIC EYE DROPS AND AN OPHTHALMIC OINTMENT (BOTH UNSPECIFIED). HER EYE RECOVERED IN ONE WEEK. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DAILIES FRESHLOOK ILLUMINATE	LENS, CONTACT (DISPOSABLE)	MVN	CIBA VISION GMBH		N0217458

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other