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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION JOHOR SDN, BHD. AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBVUNK00091
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The complaint sample has 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 on (b)(6) 2019 through the website, the consumer stated that he has been a contact lens user for several years for his myopia and astigmatism. The last ones the consumer purchased are giving him a lot of problems for reason that the contact lenses are thicker. Additional information was received on (b)(6) 2019, stating that the consumer needed a medical attention and the problem has always been the same. Further information received on (b)(6) 2019 stating the consumer is not experiencing any more discomfort. The consumer added that the reason he sought medical attention was due to a small wound in one of the eye. The treatment took several weeks and the consumer needed two medical intervention. Received additional information on (b)(6) 2019, the consumer was diagnosed of giant papillary conjunctivitis (gpc) od (right eye). Dexamethasone phosphate one drop was prescribed, four times a day for seven days; one drop three times per day for three days; one drop twice per day for three days and one drop once per day for three days. Olopatadine eye drops was given one drop every twelve hours for one month. Sodium cromoglycate eye drops to be given one drop every eight hours for one month. Received a copy of medical record on 15apr2019 which was dated (b)(6) 2018, stating that the consumer experienced ocular discomfort and sought consultation. Personal history was taken and a general impression of ¿cyliary injection temporary lower injury at vii hours para-central with mild sub-epithelial infiltrate in the indicated zone, no perilesional edema and no tyndall¿ was given to the consumer. The diagnosis upon discharge was ¿corneal abscess¿. The consumer was given treatment upon discharge, namely: moxifloxacin eye drops to be given every two hours, tobramycin ophthalmic ointment to be given five times per day, and ketorolac tromethamine eye drops to be given three times a day. The consumer was then discharge on (b)(6) 2018. Another copy of medical record was received the same day of 15apr2019 dated (b)(6) 2018, stating that the primary reason for consultation is due to ocular discomfort. Personal history was also taken and an impression of ¿od conjunctival hyperemia (more in upper quadrant), fluo (-), giant papillae in cts¿ and a diagnosis of giant papillary conjunctivitis was given to the consumer upon discharge. The treatment upon discharge were as follows: dexamethasone eye drop one drop to be given four times per day for seven days, three times per day for three days and in the morning for another three days. Olopatadine eye drops, one drop to be given every twelve hours for one month. Sodium cromoglycate eye drops, one drop to be given every eight hours for one month. The consumer was also instructed to come back for follow-up after one month. The consumer was discharge on the same date of (b)(6) 2018. Additional clarification was received on 03may2019 through telephone. The consumer added that he had a foreign body sensation in his eyes which worsened after the second or third day. The consumer also mentioned that he visited an eye care professional for the third time around (b)(6) 2019, however, no medical report was produced. The ophthalmologist confirmed that the consumer recovered with no sequelae using all the treatment mentioned in the medical report.
 
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Brand NameAIR OPTIX FOR ASTIGMATISM
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION JOHOR SDN, BHD.
#1 dpb/5 tanjung pelepas port
gelang patah
johor darul takzim johor 81560
MY 81560
Manufacturer (Section G)
CIBA VISION JOHOR SDN, BHD.
#1 dpb/5 tanjung pelepas port
gelang patah
johor darul takzim johor 81560
MY 81560
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8682099
MDR Text Key147444737
Report Number3006186389-2019-00010
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K033919
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBVUNK00091
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/10/2019 Patient Sequence Number: 1
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