MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ASKU

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypersensitivity/Allergic reaction (1907); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146); Caustic/Chemical Burns (2549); Eye Pain (4467); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

An initially reported by the consumer stated that the consumer experienced chemical burn when wearing the lens which was cared with lens care solution.Due to financial difficulties, the customer was unable to visit the emergency room and then washed the eye with a non alcon product and experience burning in the eye.Consumer also experienced bad reaction to the product, severe pain, swelling, redness while flushing out the eyes with solution on right eye.During the follow-up, the consumer reported was not able to do daily tasks, and that consumer were fine after five days.The consumer received treatment with drops of hydroxy propyl methyl cellulose.The current status of consumer¿s eye is resolved and another new eye exam is scheduled for this week.Additional information has been requested but not yet received at the time of the report.

Manufacturer Narrative

H.3., h.6.: 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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

H3, h6: 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: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18888744
• MDR Text Key: 337477697
• Report Number: 1610287-2024-00006
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2024

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 Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 05/23/2024
• Supplement Dates FDA Received: 06/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BIO TRUE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male