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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 Erosion (1750); Corneal Abrasion (1789); Pain (1994); Red Eye(s) (2038)
Event Date 07/01/2017
Event Type  Injury  
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).
 
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.
 
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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
MDR Report Key6820019
MDR Text Key256764804
Report Number1065835-2017-00024
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
K072777
Number of Events Reported1
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 Received08/25/2017
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 NumberA0492156
Other Device ID Number000000000010039285-155671200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberNOT APPLICABLE

Patient Treatment Data
Date Received: 08/25/2017 Patient Sequence Number: 1
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