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

Catalog Number CBV92001360

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problems Erosion (1750); Corneal Abrasion (1789); Pain (1994); Red Eye(s) (2038)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

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.No complaint or manufacturing trend was identified.The root cause could not be determined.(b)(4).

Event Description

It was initially reported by a female patient via telephone that the contact lens was torn in her eye and it was difficult to remove.The patient experienced tearing, pain and eye redness while trying to remove the lens.Medical attention was sought to remove the contact lens and the eye care provider (ecp) saw a deep corneal scratch after removing the contact lens in the right eye.The patient was given ofloxacin eye drops taken several times a day for five days.Further information was received per doctor's examination that the patient's right eye had a deep scratch on the regular chamber and was diagnosed with re conjunctival foreign body corneal erosion due to contact lens but there were no signs of infection.The patient's pupil was round and reactive but the patient's eye recovery remained unknown.Further information was received via telephone on (b)(6) 2017 that the patient's eye was completely recovered.

Manufacturer Narrative

This is the first of the two reports for the same patient involving two lot numbers of the same product.Refer to (b)(4) for the reported lot number a0492156.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.(b)(4).

Manufacturer Narrative

Removed other remedial action value "unknown" from previously submitted regulatory report/s.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 CORPORATION; 11460 johns creek parkway; duluth GA 30097
• MDR Report Key: 6820019
• MDR Text Key: 83625300
• Report Number: 1065835-2017-00024
• 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: consumer,foreign,other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: CBV92001360
• Device Lot Number: A0492156
• Other Device ID Number: 000000000010039285-155671200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Patient Outcome(s): Other