FDA Adverse Event Injury Summary report: N

BIOFINITY TORIC (COMFILCON A)

MDR report key: 1940516 · Received December 21, 2010

Report

Report Number: 9614392-2010-00018
Event Type: Injury
Date Received: December 21, 2010
Report Date: November 29, 2010
Manufacturer: COOPERVISION MANUFACTURING, LTD.
Product Code: LPM
PMA / PMN Number: P080011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JM
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

EVAL METHOD: NO LOT INFO, NO LENSES, NO DEVICE INFO, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: WE ARE REPORTING THIS BECAUSE WE CANNOT CONFIRM THAT THERE WAS NO PERMANENT IMPAIRMENT OR PERMANENT DAMAGE. THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADD'L INFO.

Description of Event or Problem · 1

PATIENT WAS EXPERIENCING PAIN WITH HER LEFT EYE AFTER FALLING ASLEEP WITH HER BIOFINITY TORIC CONTACT LENSES. ON EXAMINATION, THE PATIENT HAD A VISUAL ACUITY OF 20/20 OD AND 20/30 OS. HER RIGHT CORNEA WAS CLEAR, BUT SHE HAD TWO CORNEAL ULCERS ON HER LEFT CORNEA. THE LEFT CONJUNCTIVA WAS 'MARKEDLY INJECTED." ANTERIOR CHAMBERS WERE DEEP AND QUIET. IOPS WERE NORMAL AT 16MMHG OU. FUNDOSCOPY REVEALED HEALTHY OPTIC DISCS AND MACULAE. THE PATIENT IS BEING TREATED WITH AN INTENSIVE TOPICAL ANTIBIOTIC REGIMENT, AND IS RESPONDING WELL TO TREATMENT.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other