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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION CORPORATION UNKNOWN CONTACT LENS

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CIBA VISION CORPORATION UNKNOWN CONTACT LENS Back to Search Results
Catalog Number CBVUNK00090
Device Problem Insufficient Information (3190)
Patient Problem Corneal Decompensation (1790)
Event Type  Injury  
Manufacturer Narrative
The complaint sample has not returned for evaluation; the lot number is unknown. 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 documented in a literature journal publicized on december 2009, there was one case of corneal erosion reported in relation to both the contact lens and the contact lens care product. Since the adverse event was noted from a literature report, additional information can not be obtained.
 
Manufacturer Narrative
Product manufacturing site updated to correct product involved. Manufacturer report number corrected and reported under manufacturing report number 1610287-2018-00039; (b)(4). All future follow up regulatory reports will be linked to this updated manufacturing number. (b)(4).
 
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Brand NameUNKNOWN CONTACT LENS
Type of DeviceUNKNOWN CONTACT LENS
Manufacturer (Section D)
CIBA VISION CORPORATION
333 e. howard avenue
des plaines IL 60018
MDR Report Key7843971
MDR Text Key119151422
Report Number1422160-2018-00003
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Type of Report Initial,Followup,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBVUNK00090
Device Lot NumberASKU
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 09/04/2018 Patient Sequence Number: 1
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