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

Catalog Number CBV92003420

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

Patient Problems Unspecified Infection (1930); Pain (1994); Ulceration (2116); Burning Sensation (2146); Excessive Tear Production (2235); No Code Available (3191)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not 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.This is the first of two reports for the same patient involving two lot numbers.It is unknown which contributed to the event.Refer to 2019-27619-02 for the reported lot number 297021f.(b)(4).The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by a government health agency on 12apr2019 via letter with reference number mw5083962, a female consumer had experienced a sudden onset of severe pain after wearing the alleged contact lenses last (b)(6) 2018.The consumer removed the lenses upon returning home from work and confirmed that she felt an unrelenting pain, excessive tearing and light sensitivity on the eye.She then decided to seek medical help and was later diagnosed with a large unspecified ulceration which was 4.2 x 4.1 in size.The consumer was given antibiotics with an unspecified dose and frequency such as vancomycin and tobramycin.A culture and sensitivity test was done which had showed a positive result of fungus fusarium.She confirmed that the events did not get better even after taking antibiotics and added that could only see hand motion on her right eye.The consumer was also given natamycin drops and oral voriconazole to treat the infection.She had never used the contact lenses while sleeping, swimming or going to hot tubs.The consumer stated that she had never worn the lenses past the time recommended, and had never used water or saliva for cleaning.She also added that she had followed the directions for use and had replaced the case with each new purchase.Scheduled medical visits, laboratory tests, and other treatment modalities were not disclosed.The consumer's eye status was not confirmed.As of 16apr2019, additional information was received from the consumer via telephone.She confirmed that she had also experienced burning and stinging accompanied with pain and was diagnosed to have developed an ulcer overnight on her right eye.The consumer was treated in an emergency room.She indicated that she used a contact lens solution together with the alleged contact lens product.The consumer claimed that both products caused the adverse event.She added that she was very diligent in her eye care routine and had no issues prior to the event date.Medical records containing more data about the event such as treatment, history and laboratory tests were not supplied.The consumer's current eye condition remains unknown as she refused to provide more information about the event.Further details cannot be obtained.

Manufacturer Narrative

H.3., h.6.: the actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested including package integrity review, complaint history query, review of sterilization process, and trend analysis.The site also conducted manufacturing history records review for the complaint lot, the records showed that the product met specifications at the time of release.A trend related investigation was performed; no trend could be identified.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX AQUA MULTIFOCAL
• 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
• MDR Report Key: 8594054
• MDR Text Key: 144538742
• Report Number: 3006186389-2019-00008
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: CBV92003420
• Device Lot Number: 10411178
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN.; CALCIUM WITH VITAMIN D.; DULOXETINE.; NAPROXEN.; ZOLPIDEM TARTRATE.; ATORVASTATIN; CALCIUM WITH VITAMIN D; DULOXETINE; NAPROXEN; ZOLPIDEM TARTRATE
• Patient Outcome(s): Other