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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
Catalog Number CBV92000509
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ulcer (2274)
Event Type  Injury  
Manufacturer Narrative
This is the first of two reports for the same patient involving two lot numbers of the same product. It is unknown which contributed to the event. Refer to (b)(4) for the reported lot number 31259239. 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. The manufacturer internal reference number is: (b)(6).
 
Event Description
Initial complaint was received on (b)(6) 2018 from a product return with an indication that the lenses should have some problem due to the ulcer developed when used. Additional information has been requested but not yet received.
 
Manufacturer Narrative
This is the first of the two reports for the same patient involving two lot numbers of the same product. Refer to (b)(4) for the reported lot number 31285019. The complaint product was returned for evaluation 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. 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
MDR Report Key8035003
MDR Text Key126016323
Report Number9681121-2018-00012
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
K033919
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2022
Device Catalogue NumberCBV92000509
Device Lot Number31285019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/02/2018 Patient Sequence Number: 1
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