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

Lot Number A5015708

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 04/01/2017

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, on (b)(6) 2017, the consumer developed a corneal ulcer in her right eye about three weeks prior.The consumer reported that ¿she put the lens in and it felt uncomfortable, that may have caused the abrasion and ulcer.¿ consumer sought medical treatment from a corneal specialist for follow up.There was no report of medication or a treatment being prescribed.Consumer resumed contact lens wear.The patient also reported finding multiple contact lenses within a single blister package, which she attributed to the event.Further information was received from the patient, in the form of a letter and medical records from one of the treating physicians.In the hand written letter, the patient stated that, her initial visit was for corneal ulcer in right eye and that morning patient replaced contact lens and had slight irritation that subsided.The package had two contacts in one.Later that day patient kicked a mushroom that released spores and eye became irritated and the patient removed contact lenses when she went home.Patient sought for medical treatment for right eye.Per the medical records, the patient initially visited an eye care physician on 04/10/2017, it was noted in the medical records that the patient experienced discomfort involving the right eye.Patient described it as ¿burning¿, ¿irritation¿, ¿painful¿, ¿sensitive to light¿ and ¿tearing¿.These ocular symptoms were extremely bothersome that last for two or three days.The symptoms were gradually worsening and persistent.Patient stated, ¿she kicked a mushroom and brown spores went everywhere then her eyes became itchy and irritated¿.The patient was diagnosed with a corneal ulcer in the right eye (od).The patient was prescribed ofloxacin every fifteen minutes four times on that day, followed by every hour on that day and the next day and then every four times a day after the two days.The patient was advised to return to clinic and call the doctor as needed.Per follow up visit on (b)(6) 2017 (wednesday), the patient experienced blurred vision, foreign body sensation, pain, photophobia, redness and tearing in the affected right eye.Symptoms from last visit were stable.She had been using the antibiotic drops previously prescribed.The medical records noted that the surface had re-epithelialized and that the infiltrate had consolidated "some¿.The patient was prescribed dexamethasone, and was asked to continue ofloxacin.The patient was advised to return to clinic and call the doctor as needed.Follow up was scheduled for the following monday.Per follow up visit on (b)(6) 2017 (monday), symptoms were gradually improving.She described her vision as ¿good¿ and she felt better.The patient was using the previously prescribed antibiotic drops and steroid drops.Clinically, it was noted that they eye was improving, however the eye care professional (ecp) felt that it could be "masked" by the steroid drops started at the patient's last visit.Based on appearance, fungus was considered.The patient was referred to a corneal specialist to be seen that week, and was also advised to continue the previously prescribed medications.Per follow up visit on (b)(6) 2017 (friday), the patient experienced foreign body sensation in the affected right eye.Symptoms are gradually improving.She described her vision as ¿good¿.The patient was scheduled to follow-up with the corneal specialist in two weeks' time.Per follow up visit on (b)(6) 2017, the patient had no symptoms in the affected right eye.Since the last visit these symptoms had been stable.She described her vision as ¿good¿.She had been using antibiotic drops previously prescribed.Corneal examination was performed on (b)(6) 2017, it was reflected that there was a spot located in upper right anterior of the eye.It was diagnosed as anterior stromal scar.

Manufacturer Narrative

A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.The actual complaint product was not returned for evaluation.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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Remedial action changed to n/a from other in the previously submitted regulatory report/s.

Manufacturer Narrative

Remedial action changed to n/a from other in the previously submitted regulatory report/s.The manufacturer internal reference number is: 2017-37323.

• 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
• MDR Report Key: 6594787
• MDR Text Key: 76074136
• Report Number: 1065835-2017-00015
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• 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: A5015708
• Other Device ID Number: 000000000010075070-155700520
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR