MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92002040

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

Patient Problems Intraocular Infection (1933); Blurred Vision (2137)

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

Event Description

As initially reported by consumer who developed severe infections in both eyes.Consumer was unable to see, and was diagnosed with a severe infection in cornea by ophthalmologist.Consumer received treatment for the infection but vision is still blurry.Additional information has been requested but not yet received.

Manufacturer Narrative

H.3., h.6.: the actual complaint product was not returned for evaluation.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.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX NIGHT & DAY AQUA
• 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
• Manufacturer (Section G): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14238288
• MDR Text Key: 290296004
• Report Number: 9681121-2022-00002
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBV92002040
• Device Lot Number: 31432743
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other