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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, DAILY WEAR

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PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number 31279047
Device Problem Scratched Material (3020)
Patient Problems Erosion (1750); Corneal Abrasion (1789); Hyperemia (1904)
Event Date 11/21/2017
Event Type  Injury  
Manufacturer Narrative
Remedial action changed to n/a from other in the previously submitted regulatory report/s.
 
Manufacturer Narrative
Remedial action changed to n/a from other in the previously submitted regulatory report/s. The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
Sample received opened in a flat pack 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. Patient code (labeled) - eye disease. The manufacturer internal reference number is: (b)(4).
 
Event Description
On (b)(6) 2017, as initially reported, a female patient experienced contact lens issue two days after contact lens wear. She was diagnosed with an eye disease and had to undergo therapy after a specialist examination performed by an ophthalmologist. The ecp stated that the contact lens was blurry and it had a scratch that scratched the cornea. After the examination, the consumer stopped wearing contact lenses and continued with the unspecified therapy. On (b)(6) 2017, additional information was received. The patient was diagnosed with corneal erosion on her right eye (od). She was prescribed with tobramycin drops, twice a day for eight days and bepanthol eye drops, three times a day. The patient completely recovered after eight days. On (b)(6) 2017, additional information was received. The patient reported that the contact lens was not blurry prior to wearing. The physician found the contact lens blurry during examination, when lens was in the eye. Additional information was received on (b)(6) 2017. It was reported that the eye joint had a mild hyperemia and there was round erosion with a size of 1. 5 x 1. 5 mm in the projection of the pupil edge at six hours of the eye cornea. It was added that it was intensely stained with fluorescein.
 
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Brand NameAIR OPTIX NIGHT & DAY AQUA
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
MDR Report Key7145333
MDR Text Key119242775
Report Number9681121-2017-00078
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
K073459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2022
Device Lot Number31279047
Other Device ID Number000000000010043899-155700001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 12/25/2017 Patient Sequence Number: 1
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