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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD. DAILIES AQUACOMFORT PLUS; LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD. DAILIES AQUACOMFORT PLUS; LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92001362
Device Problem Defective Device (2588)
Patient Problem Corneal Ulcer (1796)
Event Date 10/19/2019
Event Type  Injury  
Manufacturer Narrative
No sample was returned for verification.This complaint for lot# c0353529 was received for complaint category ¿¿h-corneal ulcer infectious¿ and ¿lens-other¿ on 12 dec 2019.There was no other complaint received for this complaint lot since (b)(4) lenses were released on 08 nov 2018.All the in-process sampling inspections did not identify any defect for this complaint lot and all results were within specifications.Furthermore, the in-process controls were all in place and no deviations were observed to the controls during the manufacturing of this lot.Retained sample evaluation was performed and results for all tested parameters were found to be within specification.Therefore, systemic issue can be excluded, the lot is acceptable for continued distribution.This complaint is classified under category 1 incident and has been escalated to local qa for investigation.Further escalation to global escalation management (gem) is not required.All investigation results showed that no deviations were observed during the manufacturing of this complaint lot.The aql of this lot met the acceptance criteria and the final release testing results for this lot met specifications.All equipment (linear table, primary packaging, autoclave) and environmental monitoring results associated with the manufacture of this lot was found to be acceptable.Furthermore, the retained samples of the complaint lot were tested and the tested parameters were found to meet the manufacturing specifications.Therefore, a conclusive root cause could not be established during the course of this investigation.No root cause could be identified and hence no corrective action preventive action (capas) were raised.However, all complaints including this case are continuously monitored and tracked by the site.All complaint cases received by the site are also reviewed periodically.Corrective actions will be determined if required.(b)(4).
 
Event Description
It was reported by an eye care professional (ecp) that a patient experienced a possible defective lenses and was advised to stop wearing the contact lenses for a while.Additional information was received on 19dec2019 via a follow up call to the ecp.It was reported that the patient had temporarily stopped wearing the complaint contact lenses as the patient developed corneal ulcer in the right eye (od).It was noted that the patient was currently on moxifloxacin.The patient was scheduled for a follow up visit in a couple of weeks.Additional information has been requested but not yet received.
 
Manufacturer Narrative
H.3., h.6.: two hundred one (201) sealed blisters were returned.Two (2) sealed blister(s) were sampled for testing.No opened product was returned for this complaint.Sample 1, received sealed, was found to be defective- tear of 3mm at 12 o'clock position.Sample 2, received sealed, was found to meet manufacturing specifications for package integrity, ph, osmolality, surface, edge, base curve and diameter.This complaint for lot# c0353529 was received for complaint category ¿¿h-corneal ulcer infectious¿ ,"h- corneal opacity (peripheral)¿ and ¿lens-other¿ on 12 dec 2019.There was no other complaint received for this complaint lot since (b)(4) lenses were released on 08 nov 2018.All the in-process sampling inspections did not identify any defect for this complaint lot and all results were within specifications.Furthermore, the in-process controls were all in place and no deviations were observed to the controls during the manufacturing of this lot.Retained sample evaluation was performed and results for all tested parameters were found to be within specification.Therefore, systemic issue can be excluded, the lot is acceptable for continued distribution.This complaint is classified under category 1 incident and has been escalated to local quality analyst (qa) for investigation.Further escalation to global escalation management (gem) is not required.All investigation results showed that no deviations were observed during the manufacturing of this complaint lot.The aql of this lot met the acceptance criteria and the final release testing results for this lot met specifications.All equipment (linear table, primary packaging, autoclave) and environmental monitoring results associated with the manufacture of this lot was found to be acceptable.Furthermore, the retained samples of the complaint lot were tested and the tested parameters were found to meet the manufacturing specifications.General root causes for complaints related to tearing, fall into three categories: design induced - related to material fragility, manufacturing induced - small imperfections in lens (such as ¿major a¿ defects) and user induced ¿ related to lens handling by consumer.Contact lenses made with nelfilcon a material are composed of 69% water and this characteristic gives positive attributes to the lens such as lens comfort, biocompatibility and better compliance with the recommended daily disposable wear regimen.Other characteristics of this material are such that certain types of small imperfections (monitored within manufacturing operations as ¿major a defects¿), can propagate into a tear, whether induced during or post manufacturing.Therefore, the torn lens found may potentially be due to a small imperfection that has propagated into a tear after the ipi vision system inspection.However, the spc lens inspection performed after the ipi vision system inspection indicates the lot to be acceptable with no tear defect found.Hence, a potential root cause could not be established during the course of this investigation.Although, tear was found in one of the sealed blister returned, all investigation results did not identify any deviation during manufacturing of this complaint lot and there were no other complaints received for this lot, therefore, the tear is consider an isolated case and systemic issue can be excluded.In addition, since lens worn by customer was not returned, the investigation is unable to determine that similar defect was presence in the worn lens and have caused or contributed to customers¿ reported event.No root cause could be identified and hence no corrective actions preventive actions (capas) were raised.However, all complaints including this case are continuously monitored and tracked by the site.All complaint cases received by the site are also reviewed periodically.Corrective actions will be determined if required.The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
D.4.: this is the first of two reports for the same patient involving two lot numbers of the same product.Refer to (b)(4) for the reported lot number c0356936.The manufacturer internal reference number is: (b)(4).
 
Event Description
Additional information was received on 13jan2020.It was reported that the corneal ulcer resulted to a mid-peripheral corneal scar superior cornea.Additional information was received via a telephone call to the patient.It was reported that the patient was ready to restart wearing contact lenses as per the ophthalmologist.It was added that the corneal ulcer had subsided.Additional information was received on 16jan2020 via answered questionnaire from the patient.It was reported that the patient was treated with moxifloxacin three times a day for two weeks by the emergent care physician and moxifloxacin every four hours for 48 hours then four times a day for two weeks by the ecp.
 
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Brand Name
DAILIES AQUACOMFORT PLUS
Type of Device
LENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD.
133 tuas south avenue 3
tuas 63755 0
SN  637550
MDR Report Key9573231
MDR Text Key189438759
Report Number3003657720-2020-00001
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
K072777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 03/06/2020
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 Expiration Date10/31/2023
Device Catalogue NumberCBV92001362
Device Lot NumberC0353529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2020
Initial Date Manufacturer Received 12/19/2019
Initial Date FDA Received01/09/2020
Supplement Dates Manufacturer Received01/13/2020
02/14/2020
Supplement Dates FDA Received02/04/2020
03/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age13 YR
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