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

Catalog Number 00650363AB

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Ulceration (2116); Blurred Vision (2137); Discomfort (2330)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

The complaint sample has been 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.(b)(4).

Event Description

As initially reported by an eye care provider (ecp) via telephone, a male patient used the complaint product on (b)(6) 2017 and experienced blurred vision without the contact lenses.The patient was diagnosed with corneal ulceration when rushed to the hospital.Additional information was received from the ecp on (b)(6) 2017 that on (b)(6) 2017, the patient felt visual discomfort or blurred vision after two hours upon the first use of the complaint product.It was indicated that the affected eye was on the left side and it was treated with an unspecified eye drops and vitamin ointment; treatment modality and duration were not provided.The patient's eye status was improving and there was no sequela noted.Further information was received from the ecp that the ulceration was treated, however, he could not provide further information about the treatment used.

Manufacturer Narrative

The complaint product was returned for evaluation and was found to meet manufacturing specifications.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.No complaint or manufacturing trend was 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6734365
• MDR Text Key: 80747267
• Report Number: 1610287-2017-00053
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 00650363AB
• Device Lot Number: 274951F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Patient Outcome(s): Other