MAUDE Adverse Event Report: CIBA VISION STERILE MFG (CA) CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 20955

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

Patient Problems Eye Injury (1845); Acanthameba Keratitis (1945)

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not 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

As initially reported by a patient via company website, he contracted an unspecified serious eye issue while using the complaint product.Further information obtained on 01/26/2017 via email from the initial reporter states that he was diagnosed with acanthamoeba keratitis.The patient also reported that the event was ongoing, and that he had been under medical care for the past six months.Additional information has been requested but not yet received.

Manufacturer Narrative

Date received by mfr: the initial mdr was submitted with a date of 01/26/2017; the correct clock start date should have been 01/25/2017.(b)(4).

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A trend related investigation was performed; no trend could be identified.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.The product was expired at the time that the complaint report had been made.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.(b)(4).

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): CIBA VISION STERILE MFG (CA); 6515 kitimat road; mississauga, ontario L5N 2 X5; CA L5N 2X5
• Manufacturer (Section G): CIBA VISION STERILE MFG (CA); 6515 kitimat road; mississauga, ontario L5N 2 X5; CA L5N 2X5
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6347062
• MDR Text Key: 67886676
• Report Number: 8020392-2017-00002
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031521
• 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,Followup,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Lot Number: 20955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other