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 Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Ulcer (1796); Pain (1994)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.Other technical code to address customer dissatisfaction the manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by a female consumer on (b)(6) 2018 via email, contact lenses were torn in the consumer's eye and she experienced painful and severe corneal ulcer in her left eye.She had visited the eye specialist twice and was prescribed with gatifloxacin ophthalmic eye drops every hour, prednisolone every two hours and an unspecified night time gel.Symptoms had resolved.Additional information has been requested but not yet received.

• 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7539789
• MDR Text Key: 109100200
• Report Number: 3003657720-2018-00002
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• 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: CBV92001362
• Device Lot Number: C0328394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR