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

Catalog Number	0065036103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Abrasion (1789); Keratitis (1944); Red Eye(s) (2038); Blurred Vision (2137); Loss of Vision (2139); Excessive Tear Production (2235); Eye Burn (2523); Eye Pain (4467)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A reporter informed that a consumer experienced burns to her eyes after using multi-purpose disinfecting solution for some contact lenses after following the directions on the of the solutions bottle the consumer placed the contact lenses on the eyes and began to experience burning.The consumer removed the contact lenses, however, the burning continued resulting in red eyes, blurred vision, temporary loss of vision in the right eye and decrease in vision in the left eye, with tearing and photophobia.The consumer sought treatment and diagnosed with a cornea burn, cornea erosion and cornel abrasion in the right eye, and keratitis in the left eye cornea.The consumer was treated with a bandage/therapeutic contact lens, pressure patch, erythromycin, proparacaine, ofloxacin and besifloxacin.The reporter informed that the consumers eyesight seems to have returned to normal.A product sample has been requested for evaluation for this event.No further information has been received.
Additional Manufacturer Narrative
Correction g.3: incorrect date of (b)(6) 2021 as submitted on initial mdr is being corrected to (b)(6) 2021.H.3., h.6.: 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 PUREMOIST 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 ; 8175514979
• MDR Report Key: 12596662
• Report Number: 1610287-2021-00027
• Device Sequence Number: 14270250
• Product Code: LPN
• UDI-Device Identifier: 00300650361033
• UDI-Public: 300650361033
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K102860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: 02/28/2023
• Device Catalogue Number: 0065036103
• Device Lot Number: 103C8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 104 KG