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 Problem Ulceration (2116)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

It was initially reported on (b)(6) 2018 by a sales representative regarding a consumer who was diagnosed with corneal ulcer on left eye (os).Treatment were prescribed as follows: erythromycin (antibacterial) eye drops and unspecified ophthalmic ointment with unknown treatment regimen.At the time of this report, the consumer's eye symptom has not yet resolved.No further information is available at this time.Further information was received on (b)(6) 2018 from the consumer.On (b)(6) 2018, the consumer was diagnosed with corneal ulcer and the location was described as 'at the inner side of eye, closer to the top.' on (b)(6) 2018, the consumer had another appointment and was prescribed with diquafosol sodium (unspecified treatment regimen).Another visit was done on (b)(6) 2018 and the consumer's eye symptom was reported as continuing.Additional information has been requested but not yet received.

Manufacturer Narrative

Patient identifier updated to (b)(6).

• 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: 8225438
• MDR Text Key: 132340338
• Report Number: 9681121-2019-00002
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

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: 31319095
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DIQUAFOSOL SODIUM.; ECOLICIN (ANTIBIOTIC).; DIQUAFOSOL SODIUM; ECOLICIN (ANTIBIOTIC)
• Patient Outcome(s): Other