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

Catalog Number 0003610370

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

Patient Problems Hyperemia (1904); Keratitis (1944); Excessive Tear Production (2235); Discomfort (2330)

Event Date 07/05/2022

Event Type  Injury  

Event Description

Initially it was reported by a company representative on behalf of consumer who stated that the consumer started using mpds solution and contact lenses on (b)(6) 2022.The following day he experienced bilateral hyperemia, tearing and discomfort in both eyes after couple hours of use and visited an optician.He was diagnosed with corneal inflammation and was referred to the emergency room for treatment.Fixed dose combination (fdc) of levofloxacin/dexamethasone eye drop was prescribed in descending treatment regimen with a frequency of four drops for four days following three drops for four days following two drops for four days following one drop for four days along with contact lens use suspension indefinitely.Follow up information was received on 12aug2022, states that the consumer experienced infectious corneal inflammation and was treated with tobramycin plus fixed dose combination (fdc) of levofloxacin/dexamethasone in descending treatment regimen with a frequency of four drops for four days following three drops for four days following two drops for four days and one drop for four days.The current status of the consumer's eye is resolved at the time of this report.Further information cannot be obtained.

Manufacturer Narrative

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.(b)(4).

Manufacturer Narrative

H.3., h.6.: the actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested 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.A review of the compounding and filling manufacturing batch records (mbrs) found to be acceptable.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.Previously reported concomitant medical product "tobrex + ducressa" was confirmed as treatment drug in follow details and removed from concomitant drug.The manufacturer internal reference number is: (b)(4).

• Brand Name: OPTI-FREE PUREMOIST 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: 15291172
• MDR Text Key: 298559986
• Report Number: 1610287-2022-00062
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K102860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0003610370
• Device Lot Number: 10Y6X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TOBREX + DUCRESSA IN DESCENDING TREATMENT.
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Male