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

Catalog Number	0065035720
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Eye Pain (4467)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional on behalf of customer reported that consumer experienced eye redness and developed corneal ulcer in right eye.The consumer also had eye pain and eye was bothering like a sharp needle stabbing.The consumer sought medical attention.The consumer was treated with moxifloxacin 0.5% ophthalmic solution 3ml (1 drop 6 times a day).The current status of the consumer¿s eye is resolved at the time of this report.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
H.3., h.6.: 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).
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.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.The manufacturer internal reference number is: (b)(4).

• Brand Name: OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION
• Common Device Name: 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: 19119020
• Report Number: 1610287-2024-00011
• Device Sequence Number: 18232597
• Product Code: LPN
• UDI-Device Identifier: 00300650356107
• UDI-Public: 00300650356107
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K050729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 0065035720
• Device Lot Number: 10NLV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 27 YR
• Patient Sex: Female