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

Lot Number ASKU

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Ulcer (2274)

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

It is initially reported by an optician on 03/31/2017 that after being introduced to the complaint product, a patient returned twelve days later with an unspecified ulcer.The optician recommended that the consumer consult an eye care professional.Additional information was received via email on 04/14/2017.The optician reported that only the left eye was affected and prescribed an unspecified medication; treatment modality and duration were not provided.It was also reported that the patient's left upper temporal corner of the eye was affected.At the time of this report, the patient was no longer wearing lenses due to eye dryness.Additional information has been requested but not yet received.

Manufacturer Narrative

Single use device from no to yes.The manufacturer internal reference number is: (b)(4).

• Brand Name: DAILIES TOTAL 1 MULTIFOCAL
• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6516489
• MDR Text Key: 73536424
• Report Number: 9610813-2017-00008
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/24/2017
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other