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

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.

• 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 Key: 9573231
• MDR Text Key: 189438759
• Report Number: 3003657720-2020-00001
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• 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 Date: 10/31/2023
• Device Catalogue Number: CBV92001362
• Device Lot Number: C0353529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/13/2020; 02/14/2020
• Supplement Dates FDA Received: 02/04/2020; 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR