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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
Lot Number A0402855
Device Problems Difficult to Remove (1528); Torn Material (3024)
Patient Problem Corneal Ulcer (1796)
Event Date 07/17/2017
Event Type  Injury  
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. Changed salutation from ms. To mrs. The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
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. The manufacturer internal reference number is: (b)(4).
 
Event Description
As initially reported by the consumer via website, the consumer experienced torn contact lenses on the left eye (os) for four times and it happened immediately upon insertion. It was noted that the consumer consulted an optician for the first three times and went to an ophthalmologist on the fourth time to remove the small part that stuck in the os. Further information was received on 08/24/2017 via questionnaire, the consumer went to hospital (emergency) due to stuck contact lens on her os and was diagnosed with corneal ulcer. It was reported that treatment was prescribed on (b)(6) 2017 as follows: vitamin a eye ointment, to be applied between the eyelid and the eyeball two to three times a day for one week and azithromycin, one drop every morning and evening for three days. At the time of the report, the consumer's eye status has resolved without sequelae and consumer planned to resume on wearing contact lenses again. Additional information was requested but not yet received.
 
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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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6878226
MDR Text Key250011721
Report Number1065835-2017-00027
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K072777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2019
Device Lot NumberA0402855
Other Device ID Number000000000010039336-155671300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2017 Patient Sequence Number: 1
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