FDA Adverse Event Injury Summary report: N

AIR OPTIX AQUA

MDR report key: 3890553 · Received June 4, 2014

Report

Report Number: 3006186389-2014-00024
Event Type: Injury
Date Received: June 4, 2014
Report Date: December 2, 2013
Manufacturer: CIBA VISION JOHOR SDN.BHD.
Product Code: LPM
PMA / PMN Number: P010019
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE MFG INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL F/U MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

Description of Event or Problem · 1

THIS IS THE FOURTH OF FOUR REPORTS ON THE SAME PT INVOLVING FOUR PRODUCTS WITH DIFFERENT LOT NUMBERS. REFER TO MEDWATCH 3006186389-2014-00021, 3006186389-2014-00022, AND 3006186389-2014-00023 FOR A DESCRIPTION OF THE SUBSEQUENT REPORTS. IT IS UNK WHICH LOT WAS INVOLVED IN THE ADVERSE EVENT. A REPORT WAS RECEIVED (B)(6) 2013, FROM AN EYE CARE PROFESSIONAL (ECP) THAT APPROX THREE MONTHS PRIOR, A PT EXPERIENCED PAIN IMMEDIATELY UPON INSERTION OF CONTACT LENSES, AND SOUGHT MEDICAL ATTENTION AT A HOSPITAL. THE HOSPITAL ADVISED THAT SHE HAD A BACTERIAL INFECTION AND PRESCRIBED UNSPECIFIED DROPS FOR TREATMENT. THE ECP STATED THAT THE INCIDENT HAD RESOLVED AND THE PT HAD RESUMED LENS WEAR BUT NO LONGER USED EXTENDED WEAR CONTACT LENSES. A REQUEST WAS RECEIVED ON (B)(6) 2014 FROM THE ECP TO INQUIRE IF ANY SIMILAR INCIDENTS WERE REPORTED INVOLVING THE PRODUCT LOTS. THE PT HAD EXPERIENCED CORNEAL ULCERS RATHER THAN A BACTERIAL INFECTION, AS PREVIOUSLY REPORTED. NO INFO REGARDING DURATION OF EVENT OR TREATMENT MODALITY WAS RECEIVED. ADD'L INFO WAS REQUESTED BUT NOT RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
327722	AIR OPTIX AQUA	LENSES, SOFT CONTACT, EXTENDED WEAR	LPM	CIBA VISION JOHOR SDN.BHD.		10131174

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other