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 Problem Corneal Ulcer (1796)

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

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 the patient that he experienced having a corneal ulcer in his left eye which was confirmed by an eye care professional (ecp).The patient was prescribed eye drops and antibiotics (unspecified name, dosage, and duration).The patient's eye is healed and he is able to wear contact lenses again comfortably.Additional information has been requested but not yet received.

Manufacturer Narrative

The complaint product was not returned for evaluation.Retained product from the same lot was evaluated and all testing was found to be within specification.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There were no non-conformities or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.The manufacturer internal reference number is: (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: 5817444
• MDR Text Key: 50294071
• Report Number: 1610287-2016-00078
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

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: 12/31/2016
• Device Catalogue Number: 00650363AM
• Device Lot Number: 254068F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2015
• 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): Required Intervention