MAUDE Adverse Event Report: PT. CIBA VISION BATAM O2 OPTIX; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 31251001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Eye Injury (1845); Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

The complaint product has not been received 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.(b)(4).

Event Description

As initially reported by a consumer via website, the patient (his son) was not able to use complaint product for more than two days due to eye irritation on both eyes (ou).The patient consulted an eye care provider (ecp) who confirmed that the irritation was due to newly opened complaint product; misuse was ruled out.The ecp prescribed unspecified eye drops and anti-allergic medications to be used; treatment modality and duration were not provided.Further information received that day indicated that the patient had also experienced eye secretion causing him to refrain from wearing the complaint product for more than two days.It was noted that the patient presented to the ecp with the onset of bilateral ulcers after using only two pairs of the complaint product.The patient was prescribed an unspecified ocular lubricant and an unspecified ointment for treatment.The patient's eye was reported as improving.Additional information has been requested but not yet received.

• Brand Name: O2 OPTIX
• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6536971
• MDR Text Key: 74195774
• Report Number: 9681121-2017-00026
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/02/2017

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: 07/31/2021
• Device Lot Number: 31251001
• Other Device ID Number: 000000000010010888-155628100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other