MAUDE Adverse Event Report: ALCON LABORATORIES, INC. OPTI-FREE SOLUTION UNSPECIFIED; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Corneal Ulcer (1796); Irritation (1941); Pain (1994); Red Eye(s) (2038); Scarring (2061); Excessive Tear Production (2235); Discomfort (2330)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation; the lot number is unknown.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 initially reported by a female consumer on 27feb2018 via email, she had visited an ophthalmic emergency room due to abscess of the cornea.Additional information was received via emailed questionnaire answered by the consumer and bacteriological analysis results on (b)(6) 2018.It was reported that the consumer experienced discomfort with nonstop eye watering, irritation like a dust in the eye, severe redness, and pain on the left eye (os) on the first day of contact lens wear and the use of contact lens care solution.She stopped wearing contact lenses but the problem had worsened.She sought consult with an ophthalmologist and it was confirmed that there was a corneal ulcer and a scar in the os.It was added that the symptoms have resolved but there was a little point not "cicatrized".It was mentioned that the consumer already had these issues in 2016 and 2017 every time she wore new contact lenses.She experienced discomfort that had never been more than a few days, nonstop eye watering and contact lenses were stuck upon awakening and she would stop contact lens wear for a few days.Additional information has been requested but not yet received.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received via telephone conversation with the consumer on (b)(6) 2018 that symptoms had resolved with no sequelae.The consumer had resumed wearing contact lenses with caution.It was also indicated that she thought, based on the bacterial analysis, that there was bacteria in this liquid (initially present on the new lens) as well as on the lenses.The consumer confirmed that the suspected contact lens is the lens with highest correction and she did not know if the lens care solution used contributed to the event.No further data available.

Manufacturer Narrative

Corr relevant tests & lab data: the relevant test on the smdr follow-up 1 was coustine which was submitted on 03may2018; this smdr ( follow-up 2) is being submitted to indicate that the relevant test should have been colistine and that parasitology test of right corneal sampling is still in progress.(b)(4).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.The manufacturer internal reference number is: (b)(4).

• Brand Name: OPTI-FREE SOLUTION UNSPECIFIED
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 7482654
• MDR Text Key: 107213967
• Report Number: 1610287-2018-00016
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: K002589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• 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
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AIR OPTIX AQUA MULTIFOCAL; AIR OPTIX AQUA MULTIFOCAL
• Patient Outcome(s): Other
• Patient Age: 51 YR