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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD. DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD. DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92001360
Device Problem Material Split, Cut or Torn (4008)
Patient Problems Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Irritation (1941); Burning Sensation (2146); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
The complaint sample was returned for verification. All the in-process sampling inspections did not identify any defect for this complaint lot and all results were within specifications. Furthermore, the in-process controls were all in place and no deviations were observed to the controls during the manufacturing of this lot. Retained sample evaluation was performed and results for all tested parameters were found to be within specification. Therefore, systemic issue can be excluded, the lot is acceptable for continued distribution. Thus, there is insufficient information available to conclude if the reported event is related to manufacturing processes. A conclusive root cause could not be established during the course of this investigation. The manufacturer internal reference number is: (b)(4).
 
Event Description
A consumer reported experiencing a corneal ulcer with discomfort, burning, irritation and foreign body sensation; the contact lens was split into two pieces so the consumer sought medical attention for removal from the eye. The symptoms were treated with antibiotics and corticosteroids. The patients current outcome is unknown. No further information is available.
 
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Brand NameDAILIES AQUACOMFORT PLUS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD.
133 tuas south avenue 3
tuas 63755 0
SN 637550
Manufacturer (Section G)
CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD.
133 tuas south avenue 3
tuas 63755 0
SN 637550
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key10087019
MDR Text Key192159143
Report Number3003657720-2020-00003
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K072777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2022
Device Catalogue NumberCBV92001360
Device Lot NumberC0327353
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/26/2020 Patient Sequence Number: 1
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