MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92001889

Device Problem Contamination (1120)

Patient Problems Abscess (1690); Bacterial Infection (1735); Inflammation (1932); Visual Impairment (2138); Tingling (2171)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

This report originally filed as mfg report num.1422160-2017-00015, mfg site registration (b)(4).The manufacturer internal reference number is: (b)(4).

Event Description

On (b)(6) 2017, the vigilance department received a report from a pharmacy personnel that a patient experienced tingling after using the contact lenses.It was indicated that a multipurpose lens care solution was used to clean the contact lenses.It was reported that the patient visited an ophthalmologist the following day as the symptoms have aggravated, unknown if treatments were provided.The patient was reportedly hospitalized on (b)(6) 2017 due to no improvement on the patient's symptoms.The reported clinical consequences were pseudomonas abscess under the left eye, endophthalmitis, and decreased visual acuity.Further information received on 10/23/2017 via a completed questionnaire by a pharmacy intern stated that this complaint is in reference to a (b)(6) -year-old male patient.The patient had been reportedly hospitalized from (b)(6) 2017 and underwent surgical intervention (not specified but reported as a "probable" first amniotic graft membrane) on (b)(6) 2017.It was noted that cultures were taken and were positive to enterobacter cloacae, raoultella planticola, and pseudomonas aeruginosa.It was further stated that on (b)(6) 2017, the patient underwent a second amniotic membrane graft on the left eye in a context of a pseudomonas corneal abscess.Technical and procedure of the intervention include the following: debridement of the operating site; hand washing with soft soap and hydro alcoholic solution; surgery gloves; betadine disinfection in the eyelids, ciliary edge and conjunctival culs-de-sacs; operating drape to incise stuck, opened eyelids; installation of surgical microscope decontaminated with ultraviolet and steril lens filter; positioning of first and second layers of amniotic membrane graft hold by peri limbic vicryl 8.0 seam in conjunctive; shell and dressing.It was indicated that the patient was prescribed with ceftazidime eye drop one drop eight times daily, amikacin eye drop one drop eight times daily, and atropine 1% one drop three times daily.It was reported that the event had resolved with treatment.No additional information has been received.

• Brand Name: AIR OPTIX AQUA
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• Manufacturer (Section G): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7307815
• MDR Text Key: 101344902
• Report Number: 3006186389-2018-00002
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: CBV92001889
• Device Lot Number: 10338142
• Other Device ID Number: 000000000010042532-155673400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 55