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

Lot Number N1129561

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 10/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint product was not returned for evaluation at this time.The device history record and sterilization record and investigation for this lot are in progress.Upon completion of the investigation, a follow-up medwatch will be filed.

Event Description

A report was received from a sales representative that an eye care provider treated a (b)(6) male patient who had ocular irritation, photophobia and red eye after wearing a contact lens.The consumer visited the doctor on (b)(6) 2015 and was diagnosed with a corneal ulcer.The consumer was prescribed moxifloxacin, tobramycin and rinderon.(four days treatment duration, regimen not specified).Follow up visits were conducted on (b)(6) 2015.Additional information received from the treating eye care provider's office states that the symptoms presented two days before the first medical visit.The consumer had a corneal ulcer (size and location unknown) as well as a bedewing.At the (b)(6) 2015 follow up visit it was noted that the symptoms were resolved with the exception of the bedewing but that resolved one week later.The doctor classified the symptoms as severe and a result of the contact lens wear.

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.

• Brand Name: DAILIES TOTAL 1
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer (Section G): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5241266
• MDR Text Key: 31788068
• Report Number: 9610813-2015-00543
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Service Personnel
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

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: 03/31/2018
• Device Lot Number: N1129561
• Other Device ID Number: 000000000010075080-155700520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR