MAUDE Adverse Event Report: CIBA VISION CORPORATION UNKNOWN CONTACT LENS

Lot Number ASKU

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Burning Sensation (2146)

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

As reported initially via telephone thru patient oriented program on (b)(6) 2017, the patient experienced burning on both of her eyes after putting an unknown contact lenses that was cared with care clear plus.The patient added that she followed the procedure described on the package and she eventually scheduled an appointment with an eye care provider (ecp).Due to the product being strong, it burned the lens and her eyes apparently leading to multiple physician visits and surgery.In addition to that, eye redness was also noted.No further information regarding this event could be obtained.

• Brand Name: UNKNOWN CONTACT LENS
• Type of Device: UNKNOWN CONTACT LENS
• Manufacturer (Section D): CIBA VISION CORPORATION; 333 e. howard avenue; des plaines IL 60018
• Manufacturer (Section G): CIBA VISION CORPORATION; 333 e. howard avenue; des plaines IL 60018
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6878275
• MDR Text Key: 86697610
• Report Number: 1422160-2017-00013
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention