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

Catalog Number 0065036307

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Blurred Vision (2137); Halo (2227)

Event Date 06/01/2017

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.(b)(4).

Event Description

As reported initially via letter on (b)(6) 2017, the patient complained of having various vision problems after she started using aosept plus with hydraglyde.She stated that she used aosept plus with hydraglyde with her non-alcon contact lenses when the initial symptoms were felt.She experienced rainbow halos around lights several minutes after putting on the contact lenses which would disappear after five to six hours of wearing the contact lenses.She also experienced foggy vision which seemed like the contact lenses were unclear and symptoms persisted even after removing the contact lenses.The patient thought she was having a problem with her eyes, but it seemed that there was a chemical reaction between the hydraglyde, the contact lenses and her tears which caused her eyes to be sensitive.The patient added that this was the first time she suffered from recurrent corneal erosion in her 12 years of wearing contact lenses.The patient's vision had returned to normal after she switched back to aosept plus.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.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).

Manufacturer Narrative

Correction: date was not entered on supplemental device report (smdr) follow-up 1, which was submitted on 10/12/2017; this smdr (follow-up 2) is being submitted to indicate that this entry should have been 09/15/2017.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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6849181
• MDR Text Key: 85152156
• Report Number: 1610287-2017-00060
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: K142284
• 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: 12/13/2017

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: 03/31/2018
• Device Catalogue Number: 0065036307
• Device Lot Number: 265060F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 08/09/2017; 11/16/2017
• Supplement Dates FDA Received: 10/12/2017; 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2016
• 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