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

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. CATARACT PACK

  • 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
 

MEDLINE INDUSTRIES INC. CATARACT PACK Back to Search Results
Catalog Number VAL011CTASA
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/01/2018
Event Type  Injury  
Manufacturer Narrative

It was reported that during the post-operative evaluation of a patient, after an unidentified procedure, blue fibers were found in the patient's eye that the facility feels are coming from the back table cover. The facility reported that the event has occurred with eight patients. No sample has been received for evaluation. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed. This is report five of eight.

 
Event Description

It was reported that during the post-operative evaluation of a patient, after an unidentified procedure, blue fibers were found in the patient's eye.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceCATARACT PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
karen trutsch
three lakes drive
northfield, IL 60093
8476434960
MDR Report Key8218661
MDR Text Key132141292
Report Number1423395-2018-00069
Device Sequence Number1
Product Code OJK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 01/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberVAL011CTASA
Device LOT Number18IBM853
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/04/2019 Patient Sequence Number: 1
-
-