MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX FOR ASTIGMATISM; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92000509

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Pain (1994); Red Eye(s) (2038); Discharge (2225); Excessive Tear Production (2235); Discomfort (2330); Fungal Infection (2419)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.The manufacturing investigation through device history record review of lot 31320374 has been conducted.This lot has gone through all manufacturing process stages.There was no nonconformity related to the nature of complaint occurring during the manufacturing process.All in-process inspection records and final product inspection record confirmed to be within specifications.This lot has gone through 100% wet visual cosmetic inspection.The sampling taken for package integrity were within the specifications.The manufacturing site has inspected the product retain samples of lot 31320374.Based on the investigation, this lot has passed through all manufacturing process as required by the procedures.The lot was confirmed to meet all in-process and finished product specifications at the time of release.This complaint can be considered as an isolated case as there is no other similar complaint reported to this lot.No root cause can be determined.The manufacturer internal reference number is: (b)(4).

Event Description

It was reported by an optician on 19oct2019, that a consumer experienced discomfort with the contact lens on (b)(6) 2019.Upon placement of the contact lens on the left eye, discomfort was immediately felt.The contact lens were then removed, cleaned and inspected before placing back on the eye.The consumer reported discomfort and lacrimation all day long with use of the contact lens and in the evening, upon removal, the left eye continued to lacrimate.Upon waking up the next day, the left eyelids were reported to be stuck which prompted a visit to the emergency room.Additional information was received on 29oct2019, stating that acute pain, severe redness, mucopurulent discharge, and decreased vision was also experienced by the consumer.Upon visit to the ophthalmologist it was found out that the consumer had an infection due to a ¿germ¿.It was also confirmed that the consumer had an abscess.It was reported that the consumer was advised to stop the use of contact lens definitely and to rest from work.The consumer was prescribed with tobramycin and dexamethasone ophthalmic suspension, rifamycin and an unknown drug named ¿kinofine¿, the treatment modality and duration were not specified.It was reported that the consumer¿s condition was improving with sequela of visual acuity loss (unspecified) and a central ¿spot¿.Additional information was received on 31oct2019 confirming the presence of pseudomonas aeruginosa and serratia marcescens.It was also confirmed that there was no presence of acanthamoeba and fungus.A bacteriology was also submitted with the report.Additional information has been requested but not yet received.

Manufacturer Narrative

Four lenses were received sealed in blister packs.All four received samples were visually inspected and two of the samples were tested further.Testing was performed in accordance with alcon operating procedures.The two tested samples, were found to meet manufacturing specifications for package integrity, osmolality, and ph parameters, the solution was found to be clear and in specifications.Samples were also in specification for surface and edge visual criteria, power, as well as, base curve and diameter parameters.In specifications- further actions needed.A manufacturing investigation is in progress based on alcon standard operating procedures.Based on the results of the samples evaluated, the two samples were found to meet manufacturing specifications.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received on 26nov2019 from the eye care professional via email stating that the symptom has resolved and that the left eye is in its ¿final state¿.It was reported that there has been no aggravation nor improvement.The consumer was reported to return for follow up in three months.It was reported that the central task is permanent.

• Brand Name: AIR OPTIX FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• MDR Report Key: 9333965
• MDR Text Key: 167973542
• Report Number: 9681121-2019-00015
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: CBV92000509
• Device Lot Number: 31320374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 11/26/2019; 12/17/2019
• Supplement Dates FDA Received: 12/17/2019; 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR