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

Catalog Number CBV92001889

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Endophthalmitis (1835); Visual Disturbances (2140); Tingling (2171)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation; the lot number is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

On 09/11/2017, 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 non-alcon 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.Additional information has been requested but not yet received.

Manufacturer Narrative

Unopened product from the same lot as the complaint product was returned for evaluation and was found to meet manufacturing specifications.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.(b)(4).

Manufacturer Narrative

Unopened product from the complaint lot has been returned for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

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) male patient.The patient had been reportedly hospitalized from (b)(6) 2017 through (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 plauticola, 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.

Manufacturer Narrative

Catalog number updated to cbv92001889.Manufacturer report number corrected and reported under mfg report num.3006186389-2018-00002, (b)(4).All future follow up regulatory reports will be linked to this updated manufacturing number.(b)(4).

• 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 IL 81560 ; MY 81560
• MDR Report Key: 6913703
• MDR Text Key: 88138980
• Report Number: 1422160-2017-00015
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• 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
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MULTIPURPOSE CONTACT LENS SOLUTION; MULTIPURPOSE CONTACT LENS SOLUTION
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 55