MAUDE Adverse Event Report: ALCON RESEARCH, LLC OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Catalog Number 00656144AC

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

Patient Problems Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/15/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the complaint sample has 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.The manufacturer internal reference number is: (b)(4).

Event Description

The consumer experienced reaction and burnt corneas of both eyes thus discontinued the contact lens wear and used eyedrops to heal the damage.Per follow-up with chemical burn the diagnosis confirmed possible corneal toxicity/allergy.The physician requested to discontinue contact lenses use until the symptom was resolved.The current status of the consumer's eye is improving at the time of this report.Additional information has been requested but not yet received.

Event Description

Additional information received which state the consumer was treated with lubricant eye drop, frequency of one drop per two hours to ease discomfort.Consumer started wearing contact lens which was resumed along with peroxide solution.The current status of consumer¿s eye was resolved.

Manufacturer Narrative

The actual complaint product was not returned.The retained sample was evaluated for history and found in compliance.Manufacturing batch records (mbrs), microbial and chemistry showed to be acceptable.Incoming component inspection, retention testing.In process and finished product testing review shows that the manufacturing processes were in a state of control.The root cause could not be determined.The additional information is updated.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

H.3., h.6.: the complaint product was returned for evaluation and was found to meet manufacturing specifications.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.A root cause could not be determined as all testing results were within specification.The manufacturer internal reference number is: (b)(4).

• Brand Name: OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
• 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: 14827889
• MDR Text Key: 294782035
• Report Number: 1610287-2022-00047
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K021143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 00656144AC
• Device Lot Number: 10FFL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female