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

Lot Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

Complaint product from two unknown lot numbers was associated with this event.This report is for the reported contact lens power of -11.00 (left eye); an additional report will be submitted under (b)(4) for the reported contact lens power of -9.00 (right eye).The complaint sample was not made available for evaluation.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).

Event Description

As initially reported via an alcon patient orientated program on (b)(6) 2017, a female consumer informed that an incident happened between 2016 and 2017 when she had a lot of irritation.Two months after she started using the product, consumer experienced irritation and red eye.Consumer sought medical attention and was diagnosed with corneal ulcer on both eyes and infection.Ophthalmologist suspended the use of contact lenses.She was prescribed unspecified multiple eye drops for unknown duration, one for lubrication and the other one was an antibiotic.She had ¿blue light and red light treatment, a bunch of lights¿ to ¿soften the ulcer¿.Symptoms were improving, she informed she¿s getting better slowly, but is still seeing a ¿sign¿ that ¿keep passing on her eyes¿, sometimes there is a ¿white little ball¿ deep in her eye which is the ulcer that is getting smaller but it has not gone away yet.The consumer reported that she recovered with unspecified sequelae.

Manufacturer Narrative

Remedial action changed to n/a from other in the previously submitted regulatory report/s.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Remedial action changed to n/a from other in the previously submitted regulatory report/s.The manufacturer internal reference number is: (b)(4).

• 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: 6692408
• MDR Text Key: 79244765
• Report Number: 9681121-2017-00051
• 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: other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other