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 07/07/2016

Event Type  Injury  

Manufacturer Narrative

The 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

It was reported by the consumer that on (b)(6) 2016 her vision started to become cloudy after using the solution.She visited her optometrist on (b)(6) 2016, and he told the consumer that he had never seen anything like this before.Her corneas were covered in "pigment." the optometrist said that it wasn't bacterial, but gave her erythromycin just in case it could help.The consumer stopped wearing contact lenses or using the solution on (b)(6) 2016, but her vision continued to get worse.The consumer went back to the optometrist on (b)(6) 2016 and he immediately sent her to an ophthalmologist and he gave her steroid drops in case that might help, however it did not.Her vision continued to get worse.She then went to another ophthalmologist for a third opinion, since neither of the other two doctors had given a diagnosis.The new ophthalmologist deemed it to be dendritiform keratopathy from polyquaternium in the solution.The consumer noted that she was not able to clearly see to read or to drive.She felt as though she was looking through a dirty window.She also noted that the condition is "debilitating" and that she will just have to "ride it out until it clears up, which could take weeks." additional information has been requested, but not yet received.

Manufacturer Narrative

The 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.The manufacturer internal reference number is: (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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5851444
• MDR Text Key: 51339343
• Report Number: 1610287-2016-00083
• 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
• 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: 02/28/2018
• Device Catalogue Number: 0065035720
• Device Lot Number: 258406F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 08/05/2016
• 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: 02/18/2016
• 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; Required Intervention