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

Lot Number ASKU

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Scarring (2061); Ulcer (2274)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

The lot number has not been provided, however two unique identifiers were reported for this patient (contact lens powers -3.50 and -5.00 ); at the time of this report, it is not known which contact lens power is associated with the event.This report is being submitted to represent the contact lens power of -3.50 reported; an additional report will be submitted under manufacturer's reference number 2017-29638 to represent the -5.00 high power reported.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 was reported, on (b)(6) 2017, by an optician that, consumer wore this type of contact lenses since 2012 and was diagnosed with an ulcer on (b)(6) 2016.Additional information received on 04/14/2017 indicating that left eye (os) central was affected.It was reported that the consumer visited the eye care provider (ecp) three times (dates unspecified) and was prescribed an unspecified antibiotic with unspecified treatment regime.The consumer was refit into a daily wear lens, a light scar is visible.No additional information is known at this time.

Manufacturer Narrative

The previously reported contact lens power of -3.50 high contact lens was not confirmed to be part of the complaint and is not considered a suspect product in the reportable event previously submitted on 04/28/2017.Please reference the manufacturer internal reference number is: 9610813-2017-00009 for information regarding the reportable event that occurred.

Event Description

Additional information received on 04/28/2017 indicating that left eye (os) with -5.00 power was affected.No additional information is known at this time.

• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6525443
• MDR Text Key: 73810218
• Report Number: 9610813-2017-00009
• 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: 05/24/2017

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 Lot Number: ASKU
• Other Device ID 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: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other