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

Catalog Number CBV92004051

Device Problem Insufficient Information (3190)

Patient Problems Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

This is the second of four reports for the same patient involving four lot numbers of the same product.It is unknown which contributed to the event.Refer to (b)(4) for the reported first lot number a5035479.Refer to (b)(4) for the reported third lot number a5015452.Refer to (b)(4) for the reported fourth lot number a5007916.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 by an eye care clinic receptionist through email on (b)(6) 2018, the receptionist stated that one of their clients had a concern with regards to dailies total 1 contact lenses, as these have caused her corneal ulcers.Received additional information on (b)(6) 2018 stating that the consumer was diagnosed with corneal ulcers on both eyes on the (b)(6) 2018 by an ophthalmologist.She was accordingly prescribed with an unknown antibiotic eye-drops, to be instilled every hour for a week and was consequently reduced to four times a day for a month¿s duration.The consumer¿s condition had reportedly improved and later resolved through the treatment course.The consumer added that she had been using this brand of contact lenses for a few years now, but just had only recently felt the discomfort specifically with this last purchase, mentioned that it is like ¿something was in my eye when i was wearing these¿.The consumer also cited that she¿s back in wearing contact lenses after her eyes have recovered but had settled with a different brand.She did try to use the same lenses from the old pack she had but had experienced discomfort when wearing them.She further said, that she had no issues with her new lenses brand and she¿s fine with it.

Manufacturer Narrative

This is the second of four reports for the same patient involving four lot numbers of the same product.It is unknown which contributed to the event.Refer to 2018-51279-01 for the reported first lot number a5035479.Refer to 2018-51279-03 for the reported third lot number a5015452.Refer to 2018-51279-04 for the reported fourth lot number a5007916.The complaint product was returned for evaluation and was found to meet manufacturing specifications.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.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.The manufacturer internal reference number is: 2018-51279.

• 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: 7821961
• MDR Text Key: 118392114
• Report Number: 1065835-2018-00013
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: CBV92004051
• Device Lot Number: A5008007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other