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

Catalog Number 0065035720

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was 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 by the patient¿s mother, her daughter experienced red eyes with ¿holes in the eye¿ which she attributed to the product¿s use.Additional information was received on 01/12/2016 from the patient¿s mother, who stated that the patient initially presented with redness and irritation after using the product.She took her daughter to see her eye care professional (ecp) and he told them that the patient had ¿holes in her eyes¿.The patient was prescribed a steroid drop (unspecified name, dosage, or duration) which helped to clear up the issue after a few weeks.At that time, the patient had resumed contact lens wear.Additional information was received on 03/29/2016 via an adverse event form from the ecp which indicated the reported event occurred (b)(6) 2015 and follow up appointments were scheduled for (b)(6) 2015.The patient was prescribed a contact lens wearing schedule of 12-14 hours per day for two weeks, however the ecp noted that the patient was wearing 3 week old lenses at the time of the visit.The ecp indicated that the patient presented with moderate discomfort, mild redness, and infiltrates (20-30 in the right eye and 15-20 in the left eye), with the largest of the infiltrates being 1-2 mm.The infiltrates were located both peripheral and central.There was no anterior chamber reaction or discharge present.There was mild corneal staining and no scarring noted.The ecp noted that the patient was diagnosed with keratitis and was prescribed dexamethasone (steroid/antibiotic), 1 drop in both eyes 4 times a day for 4 days, then 2 times a day for 4 days, and then once a day for 4 days.The event resolved and the patient has resumed lens wear.

Manufacturer Narrative

The actual 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 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: OPTI-FREE REPLENISH 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5609777
• MDR Text Key: 43760931
• Report Number: 1610287-2016-00042
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

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: 03/31/2017
• Device Catalogue Number: 0065035720
• Device Lot Number: 251309F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2015
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR