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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. TABLE COVER IN CATARACK PACK

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MEDLINE INDUSTRIES INC. TABLE COVER IN CATARACK PACK Back to Search Results
Catalog Number DYNJ34123G
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2019
Event Type  Malfunction  
Manufacturer Narrative

It was reported that on post-operative day one, lint was discovered on the anterior chamber of patient's left eye, which underwent phacoemulsification with intraocular lens implantation. Reportedly, this lint was from the linting back table cover (taken from cataract pack). It was added that potentially the lint reached the operative site through contact with an instrument/hand piece. It was denied that patient experienced any symptom and the incident was noted during a routine post-surgical follow-up. An anterior chamber wash out, performed under sedation, was required to successfully retrieve the lint from the patient's left eye. Per report, there is no known impact to the patient or to the procedure performed and there is good surgical outcome at this time. Due to the reported incident and required medical intervention to retrieve the lint, this medwatch is being filed. The sample is not available to be returned for evaluation. A definitive root cause could not be identified at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.

 
Event Description

It was reported that on post-operative day one, linting (from the table cover) was discovered on the anterior chamber of patient's left eye. Patient required anterior chamber wash out.

 
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Type of DeviceTABLE COVER IN CATARACK PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
bermon punzalan
three lakes drive
northfield, IL 60093
MDR Report Key8491820
MDR Text Key145773113
Report Number1423395-2019-00010
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDYNJ34123G
Device LOT Number18LBO845
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2019
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 TREATMENT DATA
Date Received: 04/08/2019 Patient Sequence Number: 1
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