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

Lot Number ASKU

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Keratitis (1944); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown and the actual complaint product was not made available 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 a social media website via an email received on 12/21/2016, a consumer reported that some unspecified studies indicated that the complaint solution kills less bacteria and leads to bacteria coating the contact lens which "provokes an immune reaction in the cornea and keratitis".The consumer also reported that they experienced keratitis.The reporter added that the condition is painful and can be treated with steroids and anti-biotics.No additional information was provided at the time of this report.Additional information is not expected.

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)(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: 6266465
• MDR Text Key: 65382249
• Report Number: 1610287-2017-00006
• 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,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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: 03/10/2017
• 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