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

Model Number	OPO71
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown as it was not provided.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
During a cataract extraction procedure, the surgery reported two patients had capsular tear occur in the operative eye when using the opo71 disposable tubing pack.A description from the surgery center indicated out of 7 cases, they had 2 capsular tears and in 2 other cases, they had unstable chamber.It is unknown if there was surgical or medical intervention required.Although several attempts were made for additional information, no additional information was provided.This report is 2 of 2 reports.
Additional Manufacturer Narrative
Additional information: additional information was provided that indicated the capsular tear reported did not require a vitrectomy procedure and post op patient outcome was well.Device evaluation: the product testing could not be performed because the product was not returned for evaluation.Device inspection could not be performed, therefore the reported complaint 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 model no.Opo71, lot# 60139731.All devices met material, assembly and performance specifications at the time of product released.Conclusion: based on the investigation results there is no indication of a product quality deficiency.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: 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: 8368605
• Report Number: 3006695864-2019-00160
• Device Sequence Number: 1833146
• Product Code: HQC
• UDI-Device Identifier: 05050474534445
• UDI-Public: (01)05050474534445(17)210725(10)60139731
• Combination Product (Y/N): Y
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2021
• Device Model Number: OPO71
• Device Catalogue Number: OPO71
• Device Lot Number: 60139731
• 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: 01/31/2019
• Supplement Date Received by Manufacturer: 03/25/2019; 10/25/2020
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/18/2019; 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005