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U.S. Department of Health and Human Services

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

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CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92001360
Device Problems Difficult to Remove (1528); Torn Material (3024)
Patient Problems Corneal Abrasion (1789); Pain (1994); Red Eye(s) (2038); Corneal Infiltrates (2231); No Code Available (3191)
Event Date 07/01/2017
Event Type  Injury  
Manufacturer Narrative
This is the second 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 a0491511. 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).
 
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.
 
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Brand NameDAILIES AQUACOMFORT PLUS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION CORPORATION
11460 johns creek parkway
duluth GA 30097
Manufacturer (Section G)
CIBA VISION CORPORATION
11460 johns creek parkway
duluth GA 30097
Manufacturer Contact
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7387119
MDR Text Key104027280
Report Number1065835-2018-00004
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K072777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Patient
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Catalogue NumberCBV92001360
Device Lot NumberA0491511
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberNOT APPLICABLE

Patient Treatment Data
Date Received: 03/30/2018 Patient Sequence Number: 1
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