MAUDE Adverse Event Report: CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number ASKU

Device Problem Device Expiration Issue (1216)

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

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).

Event Description

As initially reported by an eye care provider (ecp), a patient presented corneal ulcers at the 10-11 o'clock located peripherally on the left eye.The patient reportedly used lenses that were expired last year.Additional information was received on 05/17/2017, via telephone, from the ecp that the patient's symptoms were improving and that the patient was scheduled to be refitted with contact lenses.Additional information has been requested but not yet received.

• Brand Name: DAILIES AQUACOMFORT PLUS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• 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: 6609939
• MDR Text Key: 76589624
• Report Number: 1065835-2017-00016
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• 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?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Patient Outcome(s): Other