MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED BAUSCH & LOMB ULTRA CONTACT LENSES; LENSES, SOFT CONTACT, EXTENDED WEAR

Device Problem Use of Device Problem (1670)

Patient Problems Keratitis (1944); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2023

Event Type  Injury  

Event Description

Caller stated that she has been using acuvue contact lens by johnson and johnson for about a month now and was diagnosed with limbal stem cell deficiency, keratitis and verticillata.

Event Description

Additional information received from reporter on 29-nov-2023, for mw5147285.Attached is ail addendum to the claim filed initially on 23 october 2023, attached are photocopies of the contact lenses by bausch end lomb.

• Brand Name: BAUSCH & LOMB ULTRA CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 18002273
• MDR Text Key: 326599816
• Report Number: MW5147285
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL; ALLOPURINOL; ARMODAFINIL; ARMODAFINIL; ATENOLOL; ATENOLOL; CITALOPRAM; CITALOPRAM; CRESTOR; CRESTOR; GARLIC CAPSULES; GLIPIZIDE; GLIPIZIDE; HCTZ (HYDROCHLOROTHIAZIDE); HCTZ (HYDROCHLOROTHIAZIDE); LEVOTHYROXINE; LEVOTHYROXINE, ; MEFORM ER; MEFORM ER; OMEGA 3 2100 W/ COQ10; OZEMPIC; OZEMPIC; PHILIPS RESPIRONICS DREAMSTATION 2 CPAP; PHILIPS RESPIRONICS DREAMSTATION 2 CPAP; RESTASIS; RESTASIS
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White