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

Model Number	OPO71
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The surgery center is reporting this adverse event only and did not request or require field service or clinical support.In addition, the tubing pack was discarded.A review of records related to the device including complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During a cataract procedure, a rupture capsule occurred on the operative eye resulting in a vitrectomy procedure when using the disposable tubing pack model opo71.A description from the surgery center indicated during the irrigation and aspiration (i/a) segment of the cataract procedure, there was chamber instability.The surgery center indicated after the capsular rupture occurred, the surgery center changed to low settings on the remaining procedures to prevent any more ruptures.Procedure was completed, and patient outcome is well.The tubing for the event was discarded.
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: 8511843
• Report Number: 3006695864-2019-00303
• Device Sequence Number: 11028464
• Product Code: HQC
• UDI-Device Identifier: 05050474534445
• UDI-Public: (01)05050474534445(17)210828(10)60146498
• 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
• Report Date (Section B): 11/10/2020
• 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: 08/28/2021
• Device Model Number: OPO71
• Device Catalogue Number: OPO71
• Device Lot Number: 60146498
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 11/11/2020
• 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: Required Intervention
• Date Report Sent to FDA: 01/01/2005