MAUDE Adverse Event Report: CIBA VISION CORPORATION DAILIES TOTAL 1; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number A5016024

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Corneal Ulcer (1796); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Red Eye(s) (2038); Discomfort (2330)

Event Date 02/24/2017

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

As initially reported by a consumer, she presented a corneal ulcer in the left eye (os) after wearing the complaint contact lenses.On (b)(6) 2017, the consumer began to experience discomfort and pain; she discontinued contact lens wear and began wearing her glasses.No medical attention was sought, as the ulcer was diagnosed by a colleague; the consumer noted a "point" on the cornea at the bottom left of the iris.On (b)(6) 2017, the consumer began using hexamidine and calcium chloride drops six times a day.It was reported that the consumer was scheduled to see an ophthalmologist on (b)(6) 2017.Further information was received from the initial reporter on 01/30/2017 stating that she sought medical attention from an eye care provider (ecp) on (b)(6) 2017, with the diagnosis of corneal abscess given by the ecp.The ecp stated that there was possibly an existing lesion present on the eye, which became infected and was aggravated by contact lens wear.The consumer was treated with ciprofloxacin and tobramycin every two hours.At the time of this received information, the consumer's eye redness had improved, however she still experienced episodes of itching two hours after application of the prescribed treatment.Additional information has been requested but not yet received.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.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).

• Brand Name: DAILIES TOTAL 1
• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6351945
• MDR Text Key: 68088953
• Report Number: 1065835-2017-00004
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

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: 12/31/2018
• Device Lot Number: A5016024
• Other Device ID Number: 000000000010075063-155700520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BIRTH CONTROL PILL (UNSPECIFIED); PARACETAMOL
• Patient Outcome(s): Other
• Patient Age: 28 YR