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.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 intutiv 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 1 of 5 reports.
Additional Manufacturer Narrative
Additional information/device evaluation: although, the surgery center returned the tubing packs, they were returned as a bundle of returns for a specific returns good authorization.The surgery center returned 24 opo80 tubing packs with no identifiers.The individual tubing packs could not be identified by their lot numbers; therefore, no product testing could be performed.The reported issue could not be confirmed.Manufacturing record review: per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing the tubing pack lot# 60209819.All devices met material, assembly and performance specifications at the time of product released.Historical data analysis: a search of complaints related to lot no.60209819 was conducted.The search revealed there is no additional complaint types for holes/tears in the package or any other types of complaints for the tubing pack model opo80, lot no.60209819.This is the first occurrence of units released.Complaint trending: a review of the monthly complaint trends was reviewed for the last 12 months and there have been no further occurrences of the related issues.These types of complaints will be monitored tear/hole in package.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.
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: 10073137
• Report Number: 3006695864-2020-00277
• Device Sequence Number: 19490188
• Product Code: HQC
• UDI-Device Identifier: 05050474573352
• UDI-Public: (01)05050474573352(17)211015(10)60209819
• 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 Expiration Date: 10/15/2021
• Device Model Number: OPO80
• Device Catalogue Number: OPO80
• Device Lot Number: 60209819
• 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: 05/21/2020; 10/25/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/12/2020; 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