MAUDE Adverse Event Report: BAUSCH + LOMB INCORPORATED OPITSOL-GS; MEDIA, CORNEAL STORAGE

Lot Number 2106-018

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2021

Event Type  malfunction  

Event Description

Kpc+ klebsiella oxytoca cultured from donor cornea.Cannot rule out contaminated optisol-gs transport solution since we were not able to test.The tissue was recovered into optisol-gs, lot# 2053-025, exp date: 1/8/2023 the tissue was then transferred into optisol-gs lot# 2106-018, exp 02/17/2023 after addition of amphotericin b (antifungal).

• Brand Name: OPITSOL-GS
• Type of Device: MEDIA, CORNEAL STORAGE
• Manufacturer (Section D): BAUSCH + LOMB INCORPORATED
• MDR Report Key: 13011884
• MDR Text Key: 282394202
• Report Number: MW5106069
• Device Sequence Number: 2
• Product Code: LYX
• 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
• Report Date: 12/13/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/17/2023
• Device Lot Number: 2106-018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other