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

Catalog Number CBV92001360

Device Problem Break (1069)

Patient Problem Ulcer (2274)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided and 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 initially reported by an optician on 07aug2018 regarding a patient who had broken contact lenses inside the eyes for several times.On 10aug2018, further information was received via telephone from the optician and stated that the patient has experienced broken contact lenses twice.It was reported that the last incident had made the patient go to emergency room for treatment and he was diagnosed with 'ulcer in the right eye (od)' and 'inferior punctate.' it was also stated that the patient was prescribed with unknown antibiotic and with unknown treatment modality.At the time of the report, the patient's current eye status is unknown.Additional information was received on 23aug2018 from the optician confirming that the event happened around end of (b)(6) 2018 to beginning of (b)(6) 2018.There was no report on symptoms resolution.Additional information has been requested but not yet received.

Manufacturer Narrative

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: (b)(4).

• Brand Name: DAILIES AQUACOMFORT PLUS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt GA D-638 68; GM D-63868
• MDR Report Key: 7841639
• MDR Text Key: 119035175
• Report Number: 1065835-2018-00014
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: CBV92001360
• Device Lot Number: N0635780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Date Manufacturer Received: 10/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other