FDA Adverse Event Injury Summary report: N

FREQUENCY 55 TORIC

MDR report key: 1833249 · Received September 8, 2010

Report

Report Number
MW5017372
Event Type
Injury
Date Received
September 8, 2010
Date of Event
August 7, 2010
Report Date
September 8, 2010
Manufacturer
COOPER VISION
Product Code
LPL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6)2010, VISION WAS FINE PRIOR TO PUTTING IN CONTACTS. CONTACTS WERE FROM NEW UNOPENED BOXES. DID NOT RINSE OFF CONTACT WITH MY HOME CONTACT SOLUTION -AS OPPOSED TO THE SOLUTION THE CONTACT COMES IN- BEFORE PUTTING IT IN EYE. AFTER ABOUT AN HOUR OF WEAR, A WHITE SOAP OPERA HAZE -BEST WAY I CAN DESCRIBE IT- ENCOMPASSED ENTIRE FIELD OF VISION OF RIGHT EYE. LEFT EYE WAS PERFECTLY CLEAR. RETURNED HOME AND TOOK OUT CONTACTS AND PUT ON GLASSES. WHITE HAZE WAS STILL PRESENT FOR 2-3 HOURS AND EVENTUALLY DISAPPEARED. WENT TO DOCTOR WHEN HAZE WAS STILL THERE, SEE THE INFO I GOT FROM THE DOCTOR IN SECTION 6 BELOW. ON (B)(6)2010, TRIED TO USE ANOTHER NEW CONTACT FROM THE SAME BOX RECENTLY. RINSED OUT THE RIGHT CONTACT WELL 3 TIMES WITH HOME CONTACT SOLUTION. SAME THING HAPPENED AS ABOVE. LEFT EYE WAS FINE. RIGHT EYE HAD A WHITE HAZE WHICH WAS STILL PRESENT AFTER REMOVAL OF CONTACT. THIS CONTACT WAS LEFT IN MY EYE FOR LESS TIME PRIOR TO REMOVE BUT STILL TOOK ABOUT AN HOUR AND A HALF TO RESTORE CLEAR VISION. I USED A TRIAL PAIR OF CONTACTS PRIOR TO THESE -PRIOR TO (B)(6)2010- AND THERE WAS NO PROBLEM WITH THEM. RIGHT EYE CONTACT INFORMATION: MANUFACTURER - COOPER VISION FREQUENCY 55 TORIC 8.7/14.1 -1.75 -0.75 X170 LOT 3740000907 EXPIRATION 2014/12. DOSE OR AMOUNT: 1 PAIR, FREQUENCY: MONTHLY. DATES OF USE: (B)(6)2010 AND (B)(6)2010. DIAGNOSIS OR REASON FOR USE: TO BE ABLE TO SEE INTO DISTANCES. EVENT REAPPEARED AFTER REINTRODUCTION?: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FREQUENCY 55 TORIC CONTACT LENS LPL COOPER VISION 3740000907

Patients

Seq Age Sex Outcome Treatment
1 26 YR