• 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 23 GA HIGH SPEED VITRECTOMY CUTTER; UNIT, PHACOFRAGMENTATION

  • 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 23 GA HIGH SPEED VITRECTOMY CUTTER; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number BL5623
Device Problems Mechanical Problem (1384); Insufficient Information (3190)
Patient Problems Endophthalmitis (1835); Eye Infections (4466)
Event Date 05/10/2023
Event Type  Injury  
Manufacturer Narrative
The product is not available for evaluation and the lot number is unknown.Therefore, the device history record could not be reviewed.This investigation is ongoing.
 
Event Description
The user facility in the united kingdom reported a posterior capsular break (pcr) during the cataract surgery, which was precipitated by the poor optics of the microscope and being unable to perform the anterior vitrectomy.Then the wrong vitrectomy set initially was opened, only to realized it was not possible to plug it into the machine.A second 20-gauge vitrectomy set was opened.Instructions on the phaco-machine''s screen were followed which appeared to be different from the usual routine.The vitrectomy cutter functioned (confirmed under microscope), but there was no aspiration.The tubing was checked repeatedly.The connections were redone.Surgery was increased 15-30 minutes.Three days later the patient developed endophthalmitis.
 
Manufacturer Narrative
Medical device problem code: changed from 3190 to 1384.The product is not available for evaluation and the lot number is unknown.Therefore, unable to investigate root cause.Multiple emails sent requesting patient details, but no response received.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
23 GA HIGH SPEED VITRECTOMY CUTTER
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
BAUSCH + LOMB
rochester NY 14609
Manufacturer (Section G)
BAUSCH + LOMB, INC.
3365 tree ct. industrial blvd
saint louis MO 63122
Manufacturer Contact
juli moore
3365 tree ct. industrial blvd.
saint louis, MO 63122
636226-322
MDR Report Key17075340
MDR Text Key316698439
Report Number0001920664-2023-70058
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K101325
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/10/2023
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
Device Operator Health Professional
Device Model NumberBL5623
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/06/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-