MAUDE Adverse Event Report: ALCON OPTI-FREE PURE MOIST

Lot Number 227684F

Device Problem Insufficient Information (3190)

Patient Problems Irritation (1941); Red Eye(s) (2038)

Event Date 10/16/2014

Event Type  Injury  

Event Description

My optometrist suggested that i try a different contact solution and had provided several trial size bottles.I really like the solution and had no side effects.I then purchased a two bottle pack of the same solution (opt-free pure moist by alcon) at my local (b)(6) and began to use it.Within several days of using the solution from the large bottle, i had developed very red, irritated eyes.I went and saw my optometrist and they thought it was allergies etc.Recommended throwing out current contacts and case and starting fresh after a day or two not wearing them.After inserting new contacts and while using recommended allergy drops the problem persisted.I then went traveling and started using the same solution, but from a trial size bottle.The problem disappeared.Fast forward another month.I decided to finish using a bottle of my old solution and had no problems.Then 2 days ago, i finished using the old (renu) solution and opened the second bottle from the 2 pack of opti-free, that i bought at (b)(6).Within 12 hours the very red, irritated eye problem returned.I suspect that this lot of solution is contaminated.I have both bottles still.One is 1/3 full and the second has only been used once.Brand: opti-free pure moist (14 fl oz 2 pack purchased from (b)(6)), lot number on bottles: 227684f expiration date: 2016/1 other numbers listed: h12783-0613 i reported my suspicions about contaminated solution to my optometrist and they suggested contacting (b)(6) to let them know.I have not done this yet.I don't think i am allergic to the solution, as i have used at least 3 trial size bottles from the optometrist with no issues.They only issues that i have had have stemmed from the two pack of 14 oz bottles that i purchased from (b)(6).Dates of use: (b)(6) 2014.Diagnosis or reason for use: daily storage and cleaning for contact lenses.Event abated after use stopped or does reduce: yes.Event reappeared after reintroduction: yes.

• Brand Name: OPTI-FREE PURE MOIST
• Type of Device: OPTI-FREE PURE MOIST
• Manufacturer (Section D): ALCON
• MDR Report Key: 4331394
• MDR Text Key: 5256407
• Report Number: MW5039602
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/09/2014

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?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2016
• Device Lot Number: 227684F
• Other Device ID Number: H12783-0613
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 40 YR
• Patient Weight: 77