MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS LIQUID OPTICS INTERFACE; CATALYS LIQUID OPTICS INTERFACE

Model Number	LOI-12
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that after opening the liquid optics interface (loi) box and inside tray labeled as loi-12 it was found that the loi inside the package was a different product size: loi-14.This occurred prior to start of the procedure.
Additional Manufacturer Narrative
A review of the records related to the device that included labeling, manual, trending, device history records and risk documentation reviews for the device was performed.The review of the device history record (dhr) revealed no issues as all units passed final assembly testing.It should be noted that both liquid optics interfaces or lois (loi-14) and loi-12 devices use the same testing programs and criteria for results during the leak testing and final assembly testing and therefore would not be caught at either of these testing stations.A complaint history review shows that this is the only recorded incident for information labeling involving this lot number and this product family.Based on this it was concluded that the device has a labeling deficiency.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
In follow up #1 report the date received by manufacturer was incorrectly documented as 5/5/2017.The correct date that the information was received is 6/1/2017.

• Brand Name: LIQUID OPTICS INTERFACE
• Common Device Name: CATALYS LIQUID OPTICS INTERFACE
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6385275
• Report Number: 3005675890-2017-00018
• Device Sequence Number: 16157822
• Product Code: OOE
• UDI-Device Identifier: 05050474604810
• UDI-Public: (01)05050474604810(17)170531(10)1227213
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: LOI-12
• Device Lot Number: 1227213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided; 06/22/2017
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 06/23/2017; 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1