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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX PLUS HYDRAGLYDE; EXTENDED WEAR SOFT CONTACT LENS

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CIBA VISION JOHOR SDN, BHD. AIR OPTIX PLUS HYDRAGLYDE; EXTENDED WEAR SOFT CONTACT LENS Back to Search Results
Catalog Number 000000000010119133
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Conjunctivitis (1784); Acanthameba Keratitis (1945); Red Eye(s) (2038); Burning Sensation (2146); Excessive Tear Production (2235); Eye Pain (4467)
Event Date 04/10/2023
Event Type  Injury  
Manufacturer Narrative
H.3., h.6.: the actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A health care professional reported on behalf of a consumer who experienced burning, eye pain, tearing, red eyes and was diagnosed with keratitis.Additional information was received which states that the consumer attended the consultation with conjunctival hyperemia.The ophthalmologist told the consumer to change his contact lenses as they damaged his eyes and it later turned to conjunctivitis.Follow-up information was received, which states that the consumer experienced bacterial infectious keratitis and was treated with tobramycin and dexamethasone ophthalmic drops.The current status of the consumer's eyes is resolved.Further information cannot be obtained.
 
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Brand Name
AIR OPTIX PLUS HYDRAGLYDE
Type of Device
EXTENDED WEAR SOFT CONTACT LENS
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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key17017241
MDR Text Key316104914
Report Number3006186389-2023-00011
Device Sequence Number1
Product Code LPM
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
P010019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number000000000010119133
Device Lot Number10617810
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/11/2023
Initial Date FDA Received05/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM
Patient Outcome(s) Required Intervention;
Patient SexFemale
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