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

Catalog Number CBV92001360

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Irritation (1941); Burning Sensation (2146); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

The complaint sample was returned for verification.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.Thus, there is insufficient information available to conclude if the reported event is related to manufacturing processes.A conclusive root cause could not be established during the course of this investigation.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer reported experiencing a corneal ulcer with discomfort, burning, irritation and foreign body sensation; the contact lens was split into two pieces so the consumer sought medical attention for removal from the eye.The symptoms were treated with antibiotics and corticosteroids.The patients current outcome is unknown.No further information is available.

Manufacturer Narrative

Corrected information h3., no sample was returned for verification.There was another complaint received for this complaint lot since (b)(4) lenses were released on 05feb2017, however, it is unable to determine if the complaint is related to current complaint.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.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.In addition, the complaint sample was not returned for verification.Thus, there is insufficient information available to conclude if the reported event is related to manufacturing processes.A conclusive root cause could not be established during the course of this investigation.The manufacturer internal reference number is: (b)(4).

• 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: 10087019
• MDR Text Key: 192159143
• Report Number: 3003657720-2020-00003
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: CBV92001360
• Device Lot Number: C0327353
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other