MAUDE Adverse Event Report: ALCON LABORATORIES, INC. OPTI-FREE PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ASKU

Device Problem Positioning Problem (3009)

Patient Problems Corneal Ulcer (1796); Irritation (1941); Itching Sensation (1943); Blurred Vision (2137); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.(b)(6).(b)(4).

Event Description

As reported primarily thru website on (b)(6) 2017, the patient initially complained that from the first day of wearing the contact lenses, it felt different on his eye.The patient added that he had always followed the correct maintenance or process of using opti-free puremoist.After a month of wearing the contact lenses, the patient stated that wearing them became a big discomfort.He added that he experienced foreign body sensation, scratching, and noticed his eyes having more secretions than normal causing his lens to blur a lot.Moreover, patient reported that the contact lens ¿moved with difficulties when he blinked¿ and took a long time to go back to its initial position and focus.He also added that his daily activities were affected and still feels discomfort even without the lens on.The patient went to his ophthalmologist and was diagnosed with corneal lesion and was advised to suspend the use of contact lenses.The patient stated that he discarded the contact lenses and had a month-long treatment of antibiotics and corticosteroid ¿ specifications and treatment regimens were unspecified.As per the patient, by the end of the treatment the discomfort was reduced.As reported, the patient believed that the relief in symptoms was due to him not wearing the contact lenses.However, as soon as he put new contact lenses on (from another blister of the same pack) the same signs and symptoms started again.After the said event, the patient informed that he discarded the contact lens and used anti-inflammatory eye drops and underwent some tests, which included ¿mapping and topography¿.Weeks after the treatment regimen mentioned, there was no problem identified on his ¿optic system¿, that could have been related to the events, thus, he was once again authorized to wear contact lenses by his physician.On the first day of resuming contact lens wear he once again felt the foreign body sensation, itchiness and blurring.The patient removed the contact lens and stopped wearing them; however the symptoms remained for a couple of days.The patient reported that he opened the blister pack from his left eye prescription (lens power -1.50) and put it on his left eye to test.He also added, he was able to use it normally for a few days with maintenance being done properly and no untoward event occurred.At most he just had blurriness.Additional information was received per email from the patient on (b)(6) 2017, stating that the issue occurred from march to (b)(6) 2017 and was affecting both of his eyes.The patient reported that he has been using the same brand of lenses since 2015.The patient added that the adverse events on his eyes are improving and he was not hospitalized.The patient also stated that aside from corneal lesion, his ophthalmologist also diagnosed him with irritation.Additional information has been requested, but has not been received at this time.

• Brand Name: OPTI-FREE PUREMOIST MULTI-PURPOSE 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: 6672556
• MDR Text Key: 78544355
• Report Number: 1610287-2017-00047
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K102860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 24 YR