FDA Adverse Event Injury Summary report: N

BIOFINITY (COMFILCON A)

MDR report key: 2251325 · Received September 13, 2011

Report

Report Number: 9614392-2011-00055
Event Type: Injury
Date Received: September 13, 2011
Date of Event: June 1, 2011
Report Date: August 21, 2011
Manufacturer: COOPERVISION MANUFACTURING, LTD.
Product Code: LPM
PMA / PMN Number: P080011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVENT WAS REPORTED BY THE PT DIRECTLY TO COOPERVISION'S CUSTOMER SERVICE DEPT. METHOD: NO LENSES WERE RETURNED, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULT: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT. CONCLUSION: NO CONCLUSION CAN BE DRAWN. THIS IS BEING REPORTED AS A CORNEAL ULCER WITH NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT.

Description of Event or Problem · 1

PT STATES THAT BIOFINITY (COMFILCON A) LENSES WERE PURCHASED IN (B)(6), 2010. PT PUT A NEW LENS IN THE EYE IN (B)(6) AND WAS WEARING IT FOR 5 DAYS. THE LEFT LENS SUCTIONED TO THE EYE AND PT MAY HAVE SCRATCHED THE CORNEA TRYING TO REMOVE THE LENS. ON (B)(6) 2011, THE PT WAS TREATED FOR PINK EYE WITH GENTAMICIN AND DOCTOR NOTED A 2 MM CORNEAL ULCER AT 9 O'CLOCK. PT WENT BACK ON (B)(6) 2011 FOR A F/U AND WAS TOLD THERE WAS A TEAR AND WAS PRESCRIBED ZYMAXID. PT WENT BACK FOR A F/U ON (B)(6) 2011 AND THE EYE HAD IMPROVED. PT WAS REFIT INTO A DIFFERENT CONTACT LENS AND IS SEEING 20/20.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BIOFINITY (COMFILCON A)	LPM, SOFT CONTACT LENS, EXTENDED WEAR	LPM	COOPERVISION MANUFACTURING, LTD.		6137554930

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Other