MAUDE Adverse Event Report: ALCON LABORATORIES, INC. AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Catalog Number 00650363AM

Device Problem Insufficient Information (3190)

Patient Problems Corneal Abrasion (1789); Caustic/Chemical Burns (2549)

Event Date 07/17/2016

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not been received 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.(b)(4).

Event Description

As initially reported via fda medwatch form, an end-user experienced unspecified chemical burns and an unspecified corneal abrasion on (b)(6) 2016, which did not resolve with cessation of the complaint product.Hospitalization was reported as the event outcome.Additional information has been requested but not yet received.

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.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).

Event Description

Additional information was received from the patient on 10/17/2016, with the patient stating that she experienced a corneal abrasion to the right eye (od).The reported subjective symptoms of the event included burning and stinging of the od, as well as blurry vision.Directions for the products use were discussed, with misuse of the product reported; the patient also reported that the solution bubbled in the cup more than usual.She reported that the eye was still healing per her eye care professional (ecp), and that the blurry vision had not yet resolved.The patient reported that she was still under the care and follow up of her ecp, but had resumed contact lens wear under the ecps clearance.Additional information has been requested but not yet received.

Manufacturer Narrative

Additional information has been provided regarding this complaint: upon initial receipt, an event outcome of hospitalization had been reported in the absence of a concurrent serious and reportable adverse event.Further information received on 11/08/2016 confirms that the patient was treated at the emergency room; there is currently no evidence suggesting that an in-patent hospitalization of greater than 24 hours occurred and no additional information has been received suggesting that a sight-threatening injury may have occurred.Based on the review of facts available at this time, this event is not considered serious or reportable.(b)(4).

• Brand Name: AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6013806
• MDR Text Key: 56930715
• Report Number: 1610287-2016-00105
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 00650363AM
• Device Lot Number: 260495F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 10/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/14/2016; 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2015
• 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): Hospitalization; Other