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 device evaluation: the tubing pack was returned to evaluation.A visual evaluation was performed.The visual assessment observed a hole on the tyvek lid.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.Investigations: the failure mode of ¿pinhole in the packaging¿ was not replicated through mechanical stress inflicted by simulated standard shipping and handling conditions, however, was able to be replicated when a single opo80 tubing pack was dropped from a height of 48 inches.A potential contributor for the ¿pinhole in the package¿ may be related to the opo80 tubing pack being able to move within the tyvek packaging and during its inappropriately handling by the user such as unintentional dropping of the tubing pack tray on the floor.Device labeling does contain instructions to not use the device if the package is damaged.As a proactive and precautionary measure, the current packaging will be reconfigured (and validated) to increase its durability.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The 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.A visual inspection confirmed a puncture hole on the tyvek lid.
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: 9835139
• Report Number: 3006695864-2020-00183
• Device Sequence Number: 11484586
• 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
• Report Date (Section B): 11/02/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 11/02/2020
• 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