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

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.

• Type of Device: TABLE 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 Key: 8491820
• MDR Text Key: 145773113
• Report Number: 1423395-2019-00010
• Device Sequence Number: 1
• Product Code: OJK
• UDI-Device Identifier: 10889942213535
• UDI-Public: 10889942213535
• 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,health
• Reporter Occupation: Nurse
• 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 Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ34123G
• Device Lot Number: 18LBO845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR