MAUDE Adverse Event Report: ALCON RESEARCH, LLC AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Catalog Number 0003630100

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

Patient Problems Corneal Clouding/Hazing (1878); Corneal Infiltrates (2231)

Event Type  Injury  

Manufacturer Narrative

The complaint sample has been 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

Additional information received as consumer visited a doctor and was diagnosed with corneal opacity and corneal infiltration with uniform clouding of the entire cornea.The consumer were prescribed with levofloxacin and fluorometholone eye drops.The current status of the consumer's eye was fully recovered at the time of this report.No additional information can be obtained.

Manufacturer Narrative

H.3., h.6.: the complaint product was returned for evaluation and was found to meet manufacturing specifications.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 investigation has been completed based on current information and an exact root cause for the complaint cannot be determined; therefore, specific action with regards to this complaint cannot be taken.There are no adverse trends associated with the reported event.No further action is warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND 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: 15131134
• MDR Text Key: 296885194
• Report Number: 1610287-2022-00051
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 0003630100
• Device Lot Number: 10PDV10PDV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CONTACT LENS
• Patient Outcome(s): Other
• Patient Sex: Male