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

Catalog Number CBV92004051

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Red Eye(s) (2038); Tingling (2171); No Code Available (3191)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported on 01/09/2018 that a female consumer felt pain, tingling sensation and eye redness on her right eye while wearing the contact lens on (b)(6) 2018.The consumer felt no pain but still had red eye and tingling sensation on (b)(6) 2018, the symptoms were "better" except that the ophthalmologist confirmed an abscess of the cornea.The consumer was prescribed with picloxydine dihydrochloride1 drop morning, midday and night for 7 days, tobramycin 1 drop 8 times a day for 10 days, 3/ ciprofloxacin eyewash 1 drop 8 times a day for 10 days, sodium hyaluronate 1 drop 6 times a day and ciprofloxacin ointment 1 application in the eye in the hollow of the eyelid in the evening for 7 days.The consumer was also instructed not to wear contact lenses for at least a month.At the time of the initial report, symptom resolution is unknown.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Event Description

It was reported on 09 jan 2018 that a female consumer felt pain, tingling sensation and eye redness on her right eye while wearing the contact lens on (b)(6) 2018.The consumer felt no pain but still had red eye and tingling sensation on (b)(6) 2018.On (b)(6) 2018, the symptoms were "better" except that the ophthalmologist confirmed an abscess of the cornea.The consumer was prescribed with picloxydine dihydrochloride one drop morning, midday and night for seven days, tobramycin one drop eight times a day for ten days, 3/ ciprofloxacin eyewash one drop eight times a day for ten days, sodium hyaluronate one drop six times a day and ciprofloxacin ointment one application in the eye in the hollow of the eyelid in the evening for seven days.The consumer was also instructed not to wear contact lenses for at least a month.At the time of the initial report, symptom resolution is unknown.Additional information has been requested but not yet received.

• 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: 7233596
• MDR Text Key: 98750278
• Report Number: 1065835-2018-00001
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: CBV92004051
• Device Lot Number: A5033015
• Other Device ID Number: 000000000010075065-155700520
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR