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

Catalog Number CBV92004051

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

Patient Problems Corneal Ulcer (1796); Purulent Discharge (1812); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); No Code Available (3191)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The manufacturer internal reference number is: (b)(4).

Event Description

It was reported by an eye care professional (ecp)that a patient had a corneal ulcer.The symptom resolution and treatment provided were unknown at this time.Additional information was received on (b)(6) 2019 via faxed medical records.It was reported that the patient visited the ecp on (b)(6) 2019 with a chief complaint of irritation and pain on the os.The patient bought a new batch of contact lenses and noticed that the os was irritated a day prior.The patient also complained about light sensitivity, redness and foreign body sensation in the os.Slit lamp examinations observed a 2+ generalized hyperemia in the conjunctiva of the os and ulcer on the cornea of the os.The patient was advised to discontinue contact lens wear for one week, was prescribed with moxifloxacin ophthalmic solution one drop for seven days in the os and was advised for a follow up visit three to four days after.Additional information received on the questionnaire answered by the ecp reported that the pain and discomfort experienced by the patient were mild, redness was moderate, there was watery, mucopurulent discharge, <50% corneal staining and a three mm central ulcer.The patient was diagnosed with central corneal ulcer and was confirmed that the symptoms have been resolved.

Manufacturer Narrative

No sample received at time of complaint investigation.The investigation consisted of a review of the complaint trend for category corneal ulcer infectious.A product specific investigation was not performed as no lot number was available.No sample evaluation was completed as no product was returned.There were no adverse trends identified for complaint corneal ulcer infectious for the product from (b)(6) 2017 ¿ (b)(6) 2019.As no lot number was provided and no samples were returned, a trend investigation was performed.There were no adverse trends identified for complaint categories corneal ulcer infectious and product use/user technique for the product from (b)(6) 2017 ¿ (b)(6) 2019.No corrective action preventive action is required and no further action will be taken by the manufacturing site as no specific root cause was identified.Trends and complaint investigations will continue to be monitored and action taken if warranted.The examination of lot #n1172016 confirmed that the lot met all specifications.The investigation determined that this lot is acceptable for continued distribution.The contact lenses are manufactured under very high hygiene standards.All employees are trained annually on the hygiene concept and procedures.No sample was returned for verification.A controllable complaint could not be confirmed.No deviations were found during the investigation; no negative product impact could be identified and no root cause could be determined for the reported events.The lot met all specifications.A corrective action preventive action will not be initiated since no issues were identified during the investigation.However, a trend review is conducted on a monthly basis and corrective actions will be determined if required.The manufacturer internal reference number is:(b)(4).

• 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
• MDR Report Key: 9339666
• MDR Text Key: 166953476
• Report Number: 9610813-2019-00011
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: CBV92004051
• Device Lot Number: N1172016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR