MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LIQUID OPTICS INTERFACE, SIZE 14, GEN2; CATALYS

Model Number	0180-1401
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/05/2020
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
The surgery center reported that the liquid optic interface (loi) was noted to be contaminated as the seal appeared broken out of the box before it was handed to the sterile field.
Additional Manufacturer Narrative
Correction: in review, of medwatch 3005675890-2020-00038 and per new information received, this event has been assessed as not reportable.The liquid optics interface (loi) was placed on the patient's eye; however, the loi wouldn¿t fit on the patient eye and was replaced.The loi was contaminated due to being in contact with the patient's eye and could not be reused.There was no seal that appeared broken out of the box before it was handed to the sterile field as indicated in the initial report.There will be no more information provided for mfg reporting no.3005675890-2020-00038.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
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 (b)(4) and capa-010215.

• Brand Name: LIQUID OPTICS INTERFACE, SIZE 14, GEN2
• Common Device Name: CATALYS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10400075
• Report Number: 3005675890-2020-00038
• Device Sequence Number: 16924616
• Product Code: OOE
• UDI-Device Identifier: 05050474609761
• UDI-Public: (01)05050474609761(17)200401(10)11677615
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K121091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 04/01/2020
• Device Model Number: 0180-1401
• Device Catalogue Number: 0180-1401
• Device Lot Number: 11677615
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 08/17/2020; 10/25/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/10/2020; 10/29/2020
• 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