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

Catalog Number	DYNJ34123G
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Common Device Name: TABLE COVER IN CATARACK PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8491820
• Report Number: 1423395-2019-00010
• Device Sequence Number: 1163109
• Product Code: OJK
• UDI-Device Identifier: 10889942213535
• UDI-Public: 10889942213535
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/08/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ34123G
• Device Lot Number: 18LBO845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR