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

Lot Number A0402855

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problem Corneal Ulcer (1796)

Event Date 07/17/2017

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.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by the consumer via website, the consumer experienced torn contact lenses on the left eye (os) for four times and it happened immediately upon insertion.It was noted that the consumer consulted an optician for the first three times and went to an ophthalmologist on the fourth time to remove the small part that stuck in the os.Further information was received on 08/24/2017 via questionnaire, the consumer went to hospital (emergency) due to stuck contact lens on her os and was diagnosed with corneal ulcer.It was reported that treatment was prescribed on (b)(6) 2017 as follows: vitamin a eye ointment, to be applied between the eyelid and the eyeball two to three times a day for one week and azithromycin, one drop every morning and evening for three days.At the time of the report, the consumer's eye status has resolved without sequelae and consumer planned to resume on wearing contact lenses again.Additional information was requested but not yet received.

Manufacturer Narrative

The complaint product was returned for evaluation and was 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.Changed salutation from ms.To mrs.The manufacturer internal reference number is: (b)(4).

• 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: 6878226
• MDR Text Key: 86701595
• Report Number: 1065835-2017-00027
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

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 Expiration Date: 07/31/2019
• Device Lot Number: A0402855
• Other Device ID Number: 000000000010039336-155671300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR