MAUDE Adverse Event Report: CIBA VISION GMBH DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92001362

Device Problem Material Disintegration (1177)

Patient Problems Unspecified Infection (1930); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the complaint sample has not been returned for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).

Event Description

It was reported by a consumer via website on 07mar2019 that the contact lenses had broken in several pieces inside the eye more than five times which caused him unspecified infection and ulcers. Additional information received via email from the consumer on 09mar2019 stated that he had cured the irritations and infections at home using unspecified drops that the pharmacist prescribed. He did not need medical help, felt fine and was wearing glasses. 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 GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer (Section G): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8460833
• MDR Text Key: 140213290
• Report Number: 9610813-2019-00002
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/31/2021
• Device Catalogue Number: CBV92001362
• Device Lot Number: N0641736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/28/2019 Patient Sequence Number: 1