MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC LIQUID OPTICS INTERFACE; CATALYS LIQUID OPTICS INTERFACE

Model Number	LOI-12
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported by the account that the liquid optics interface (loi) product was not sealed when package was opened.The product was requested but it was reported that unfortunately they disposed it.
Additional Manufacturer Narrative
Correction: conclusion code 67.Code 67 was not included in initial report.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: LIQUID OPTICS INTERFACE
• Common Device Name: CATALYS LIQUID OPTICS INTERFACE
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7701225
• Report Number: 3005675890-2018-00056
• Device Sequence Number: 1107522
• Product Code: OOE
• UDI-Device Identifier: 05050474604810
• UDI-Public: (01)05050474604810(17)190430(10)8215949
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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): 10/30/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: LOI-12
• Device Catalogue Number: LOI-12
• Device Lot Number: 8215949
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 08/24/2018; 10/25/2020
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/17/2018; 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005