MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. COMPACT INTUITIV PACK DISPOSABLE TUBING SET; PHACO TUBING

Model Number	OPO80
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown as it was not provided.Expiration date is unknown at this time.Manufacturer date is unknown at this time.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A surgery center reported observing holes worn into the tyvek lid of a compact intuitiv pack disposable tubing set model opo80.The surgery center had concerns the packaging had been comprised and the tubing pack was no longer sterile.This is 3 of 3 reports.
Additional Manufacturer Narrative
G9: correction: in review, of medwatch 3006695864-2020-00286 and per new information received, this event has been assessed not reportable.The tubing pack was received, and evaluation found no holes on the product as indicated in the initial report.There will be no more information provided for mfg reporting no.3006695864-2020-00286 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 nr-0148919 and capa-010215.

• Brand Name: COMPACT INTUITIV PACK DISPOSABLE TUBING SET
• Common Device Name: PHACO TUBING
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10073226
• Report Number: 3006695864-2020-00286
• Device Sequence Number: 2628769
• Product Code: HQC
• UDI-Device Identifier: 05050474573352
• UDI-Public: (01)05050474573352(17)210905(10)60204287
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K060366
• 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 Model Number: OPO80
• Device Catalogue Number: OPO80
• Device Lot Number: 60204287
• 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: 04/24/2020
• Supplement Date Received by Manufacturer: 06/04/2020; 10/25/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/24/2020; 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