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.

• 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
• Manufacturer (Section G): CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD.; 133 tuas south avenue 3; tuas 63755 0; SN 637550
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• 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
• Reporter Country Code: AR
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care 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

• Device Expiration Date: 01/31/2022
• Device Catalogue Number: CBV92001360
• Device Lot Number: C0327353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 05/26/2020 Patient Sequence Number: 1