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

Lot Number 31256060

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blurred Vision (2137)

Event Date 07/01/2017

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.(b)(4).

Event Description

As initially reported by a family member, a consumer had a two-month history of blurry vision, with contact lenses moving upwards in the eye ¿as if it was with fungus.¿ the family member reported that the consumer was involved in a car accident, for which no injury was reported, attributed to the blurry vision; the consumer was also involved in a subsequent motorcycle accident on (b)(6) 2017, for which he was hospitalized, also attributed to the blurry vision that the consumer experienced.Further information received from both the initial reporter and the consumer stated that the consumer had struck both a motor vehicle and a cow with his motorcycle, due to reported visual issues.It was confirmed that the consumer was released from the hospital on (b)(6)2017, being treated with saline solution and unspecified medications.Additional information has been requested but not yet received.

Manufacturer Narrative

Two opened samples in a flat case were returned for evaluation and were found to meet manufacturing specifications.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.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.

• 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: 6935361
• MDR Text Key: 89152657
• Report Number: 9681121-2017-00070
• 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: foreign,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Lot Number: 31256060
• Other Device ID Number: 000000000010010899-155628100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2016
• 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): Hospitalization; Other
• Patient Age: 19 YR