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

Catalog Number 0065036339

Device Problems Inadequate Instructions for Non-Healthcare Professional (2956); Packaging Problem (3007)

Patient Problem No Code Available (3191)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Investigation including root cause analysis is in progress.(b)(4).

Event Description

As reported by a consumer via a medwatch form received on 07/13/2016, on (b)(6) 2016 the consumer misused the product thinking it was "similar to other eye care solutions experiencing "devastating pain as if acid had been put into eye" and suffered "chemical burn with corneal damage, which is now permanent" the consumer expressed dissatisfaction stating that the package design and warning labels were not enough to prevent the event.The consumer stated that the event did not resolve after stopping the use of the solution.Additional information has been requested, but has not been received yet.

Manufacturer Narrative

The lot number of the complaint product is known, but the actual complaint product was not returned for evaluation.A retain sample from a different lot was evaluated and was found to meet specifications.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).

• 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: 5850139
• MDR Text Key: 51262256
• Report Number: 1610287-2016-00082
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 0065036339
• Device Lot Number: 247346F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability