MAUDE Adverse Event Report: CIBA VISION CORPORATION UNKNOWN CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBVUNK00090

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cataract, Induced (1767); Corneal Ulcer (1796); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation; the lot number is unknown. 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

As initially reported by a consumer via email on 11oct2020, consumer stated that on an unknown date the consumer experienced ulceration caused by the lens ended with a scar in the middle of the cornea and an infection. Only 25% of the cornea are good and is just like cataracts. Symptoms outcome was resolved with herbal remedies which could not be cured by physician not even in the best recognized hospital. Additional info has been requested but not yet available.

• Brand Name: UNKNOWN CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION CORPORATION; 333 e. howard avenue; des plaines IL 60018
• Manufacturer (Section G): CIBA VISION CORPORATION; 333 e. howard avenue; des plaines IL 60018
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 10705497
• MDR Text Key: 212296045
• Report Number: 9681121-2020-00005
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CBVUNK00090
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/20/2020 Patient Sequence Number: 1