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

Lot Number 31183472

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682)

Patient Problem Eye Injury (1845)

Event Date 05/05/2017

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.A trend related investigation was performed; no trend could be identified.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 email, experienced eye irritation after two days of wearing the product in question.Medical attention was sought and the eye care provider (ecp) prescribed an unspecified eye drop due to irritation in the cornea; treatment modality and duration were not provided.A new contact lens was used but the consumer experienced the same issue and had difficulty taking out the contact lens as it seemed glued in the eye.Additional information was received on (b)(6) 2017, it was noted that the consumer presented to the ecp with bilateral corneal lesions due to contact lens.The consumer was treated with fluoroquinolone antibiotic for seven days every four hours and fluoretolone acetate for seven days every eight hours.The events were resolved with unspecified corneal sequelae.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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6681734
• MDR Text Key: 78847108
• Report Number: 9681121-2017-00049
• 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
• Type of Report: Initial
• Report Date: 06/30/2017

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: 05/31/2020
• Device Lot Number: 31183472
• Other Device ID Number: 000000000010021523-155628100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2017
• Initial Date FDA Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2015
• 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
• Patient Age: 30 YR