• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAUSCH + LOMB INCORPORATED OPITSOL-GS; MEDIA, CORNEAL STORAGE Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OPITSOL-GS
Type of Device
MEDIA, CORNEAL STORAGE
Manufacturer (Section D)
BAUSCH + LOMB INCORPORATED
MDR Report Key13011884
MDR Text Key282394202
Report NumberMW5106069
Device Sequence Number2
Product Code LYX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Date02/17/2023
Device Lot Number2106-018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/14/2021
Patient Sequence Number1
Patient Outcome(s) Other;
-
-