ACUVUE ADVANCE FOR ASTIGMATISM BRAND

Report

Report Number: 1033553-2013-00094
Event Type: Injury
Date Received: August 5, 2013
Date of Event: July 21, 2013
Report Date: August 5, 2013
Manufacturer: VISTAKON
Product Code: LPL
PMA / PMN Number: K032340
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: ID, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

UNSUCCESSFUL ATTEMPTS WERE MADE TO LOT, PRODUCT INFO, AND THE ER CONTACT INFO. ADDITIONAL INFO WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. (B)(4). METHOD - DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. CONCLUSIONS: NO CONCLUSIONS CAN BE DRAWN.

Description of Event or Problem · 1

ON (B)(6) 2013 A PT REPORTED A CORNEAL ULCER OD RESULTING FROM A STAPH INFECTION. SHE WAS WEARING ACUVUE ADVANCE CONTACT LENSES (CL) WHEN THE EVENT OCCURRED AND USED OPTI-FREE PURE MOIST LENS CARE SOLUTION; WEAR AND REPLACEMENT SCHEDULES WERE NOT REPORTED. THE PT EXPERIENCED RED EYE AND LID PUFFINESS; SHE VISITED AN ER AND WAS PRESCRIBED AN UNK OINTMENT. SHE EXPERIENCED AN INCREASE IN LID SWELLING AND VISITED AN URGENT CARE FACILITY. PREVIOUS MEDS INCLUDED TOBRAMYCIN 1 DROP OU QID X 7 DAYS; MDR #1033553-2013-00093 FOR OD. ON (B)(6) 2013 OUR FIRM CONTACTED THE URGENT CARE CENTER AND WAS TOLD THAT THE PT RETURNED ON (B)(6) 2013 COMPLAINING OF OS PAIN OS AND WAS DIAGNOSED WITH A CENTRAL CORNEAL ULCER OS. SHE WAS TREATED WITH CIPROFLOXACIN 1 DROP QHR X4, THEN Q2HRS X4 THEN Q4HRS. BCVA ON (B)(6) 2013 20/40 OS; BCVA WAS NOT REPORTED ON (B)(6) 2013. NO OTHER DATES OF SERVICE WERE PROVIDED. THIS REPORT IS FOR THE CORNEAL ULCER EVENT OS DIAGNOSED ON (B)(6) 2013.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
367045	ACUVUE ADVANCE FOR ASTIGMATISM BRAND	SOFT WONTACT LENS	LPL	VISTAKON	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR		Required Intervention	OPTI-FREE PURE MOIST LENS CARE SOLUTION