MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED CONTACT LENSES; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number S35118251

Device Problems Product Quality Problem (1506); Fungus in Device Environment (2316); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2023

Event Type  malfunction  

Event Description

Opened my contact lens package and observed a blackened dot with feathered edges growing on the lens itself--appearing to be fungus or mold.My uncle who is an optometrist inspected the blemish and recommended to not use the entire lot, and to report this immediately.As there is a possibility there is a contamination in all of the lenses and/or solution, i have discontinued the use of all lenses.There was liquid inside of the contact lens container preopening, and was not exposed to tap water or any other substance post-opening.This suggests there was no puncture post production that could have led to the growth-- likely occurred in manufacturing setting.The lenses are from bausch & lomb incorporated, and were directly delivered to (b)(6).The lense information is as followed: pwr (f'v) -3.00, lot: s35118251, manufacture date: 2023-09-03, expiration date: 2028-08-01.I have resealed the lens foil with tape, then placed it in a plastic baggie.The lens is still moist and the growth is intact and untouched by outside source.The package of contacts was picked up from the (b)(6) location on november 27th, 2023 between 5:30-6pm.The contact lenses have been unexposed to extreme temperature shifts, or sunlight.It has since been stored indoors, inside of the original packaging, in an unexposed drawer.I have not fully inspected all other lenses but from what i have seen, the others have no visible spores.However, this does not imply they are not contaminated.Please contact me on how to proceed with lab testing.I would like fda sponsored lab testing as an option.But please let me know if i need to proceed with external testing, and reimbursement if possible.And also, please contact me if you and bausch & lomb incorporated will be in contact about this test.I do not want them to be the one's handling the preliminary test of this contaminant, and i would please like to be kept in the loop with external correspondences.

Event Description

Additional information received on 03-jan-2023 for mw5149652.Update to procode information.

• Brand Name: CONTACT LENSES
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 18411252
• MDR Text Key: 331640165
• Report Number: MW5149652
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/25/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: S35118251
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1