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

Model Number	OPO71
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A surgery center reported observing the tyvek lid partially open on the tray of a signature disposable tubing set pack model opo71.It was reported the observations were noted upon opening the box.No additional information was provided.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation ¿ yes, returned to manufacturer on 12/3/2019.Section h3: device returned to manufacturer ¿ yes.Device evaluation: the tubing pack lot no.60192483 was returned.The tubing pack was partially opened.Thermal adhesive transfer remnants were visible along the lip of the tray flange, indicating the lids were properly sealed.Without further information obtained from the reported event, it¿s unknown how or when the reported events occurred.A search on complaints related to lot number lot# 60192483 was conducted using catsweb system and the historical data provided by post-market safety surveillant for complaints for the last 12 months.There was no related complaint found.Manufacturing records review: the manufacturing records for the product were reviewed.Per manufacturing records review there is no related non-conformity or deviations were issued during manufacturing the lot# 60192483.Conclusion: based on the information obtained, product malfunction cannot be confirmed.The tubing tray was received already opened, with the thermal adhesive was visible on the tray, and 100% inspection performing by manufacturing prior to final packaging process, the possibility of this issue occurred during the manufacturing process is very low.No failure investigation is required at this time.Johnson & johnson surgical vision will continue to monitor this type of complaints.As a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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 (b)(4) and capa-(b)(4).

• Brand Name: SIGNATURE PACK, DISPOSABLE TUBING
• 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: 9535099
• Report Number: 3006695864-2019-01023
• Device Sequence Number: 3388913
• Product Code: HQC
• UDI-Device Identifier: 05050474534445
• UDI-Public: (01)05050474534445(17)220701(10)60192483
• Combination Product (Y/N): Y
• Initial Reporter Country: FI
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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: 07/01/2022
• Device Model Number: OPO71
• Device Catalogue Number: OPO71
• Device Lot Number: 60192483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/13/2020; 10/25/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 02/05/2020; 11/05/2020
• 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