MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATARACT PACK

Catalog Number VAL011CTASA

Device Problem Device Contamination with Chemical or Other Material (2944)

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.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product, procedural, or retrieval details to the manufacturer.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 three 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.

• Type of Device: CATARACT 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 Key: 8218438
• MDR Text Key: 132203427
• Report Number: 1423395-2018-00067
• Device Sequence Number: 1
• Product Code: OJK
• UDI-Device Identifier: 10889942021376
• UDI-Public: 10889942021376
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• 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 Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VAL011CTASA
• Device Lot Number: 18IBM853
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other