MAUDE Adverse Event Report: CIBA VISION CORPORATION UNKNOWN CONTACT LENS

Lot Number ASKU

Device Problem Torn Material (3024)

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

It was initially reported by the consumer on (b)(6) 2017 that a corneal ulcer has been experienced in the past due to an unspecified contact lens that tore when worn.Symptoms have resolved.Additional information has been requested but not yet received.

Manufacturer Narrative

The lot number was not provided and 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).

• Brand Name: UNKNOWN CONTACT LENS
• Type of Device: UNKNOWN CONTACT LENS
• Manufacturer (Section D): CIBA VISION CORPORATION; 11460 johns creek parkway; duluth GA 30097
• Manufacturer (Section G): CIBA VISION CORPORATION; 11460 johns creek parkway; duluth GA 30097
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6864142
• MDR Text Key: 86080099
• Report Number: 1065835-2017-00026
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

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 Lot Number: ASKU
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/20/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other