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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR

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PT. CIBA VISION BATAM AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number 31160284
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Foreign Body Sensation in Eye (1869); Unspecified Infection (1930); Itching Sensation (1943); Ulcer (2274); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
This is the first of two reports for the same patient involving two complaint product lot numbers; this report represents lot number 31160284. The complaint product has not been 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. (b)(4).
 
Event Description
As initially reported by a patient, she felt ongoing discomfort with contact lens wear starting in (b)(6) 2016. In (b)(6) 2016, the patient experienced eye redness and itching. The patient sought medical attention with three different eye care providers (ecp). The patient was diagnosed with "small ulcers in the eye" and resumed contact lens wear after the ecp stated that her eyes were "cured. " the patient experienced ongoing itchiness after resuming contact lens wear, for which she was treated for an infection; the patient was advised to discontinue contact lens wear for three days during this time. Upon resuming contact lens wear in (b)(6), the patient experienced similar symptoms, inclusive of foreign body sensation. At that time, her ecp advised her to discontinue use of the complaint product, suggesting that the symptoms could be attributed to a lack of oxygenation from contact lens wear. The events have resolved, with patient not wearing contact lenses. Further information received from the patient clarified that the following medications were prescribed: anti-inflammatory eye drops, antibiotic eye drops, and a steroid eye drop (the dosages and treatment dates of the medications were not specified). Additional information has been requested but not received.
 
Manufacturer Narrative
This is the first of two reports for the same patient involving two complaint product lot numbers; this report represents lot number 31160284. The actual complaint product was not returned for evaluation. A trend related investigation was performed; no trend could be identified. 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. The root cause could not be determined. (b)(4).
 
Manufacturer Narrative
This is the first of two reports for the same patient involving two complaint product lot numbers; this report represents lot number 31160284. Unopened samples from this reported complaint lot were returned for evaluation and were 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).
 
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Brand NameAIR OPTIX FOR ASTIGMATISM
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
PT. CIBA VISION BATAM
beringin kav. #204 batamindo
industrial park muka kuning
pulau batam 29433
ID 29433
Manufacturer (Section G)
PT. CIBA VISION BATAM
beringin kav. #204 batamindo
industrial park muka kuning
pulau batam 29433
ID 29433
Manufacturer Contact
rita lopez
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514846
MDR Report Key6230331
MDR Text Key64133684
Report Number9681121-2017-00001
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K033919
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,Followup
Report Date 04/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2020
Device Lot Number31160284
Other Device ID Number000000000010035961-155670800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/06/2017 Patient Sequence Number: 1
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