Johnson & Johnson Surgical Vision, Inc.

眼力健（上海）医疗器械贸易有限公司报告，由于非散光矫正型TECNIS®人工晶状体在生产时带有散光矫正型基准标记，生产商强生视力康公司 Johnson & Johnson Surgical Vision, Inc.对人工晶状体（国械注进20233160195）主动召回。召回级别为二级召回。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。 附件：医疗器械召回事件报告表 2023年7月26日眼力健（上海）医疗器械贸易有限公司（召回报表）.pdf

Organizers of the[PACK]out conference have been burning the midnight oil to bring attendees an impressive program featuring movers and shakers in the medical packaging industry. Now in its second year, the go-to event takes place in Austin, Texas, from May 9-11, 2023. Sessions are geared to all industry professionals — from the novice to the seasoned packaging engineer — and cover every facet of packaging. Attendees can pick and choose from a variety of curated tracks aimed at furthering knowledge, perfecting skills, and building lasting connections. Pressing topics include ethylene oxide (EO) sterilization safety concerns, robust packaging designs, and the latest sustainability challenges. Concurrent sessions on Wednesday are categorized by Foundational tracks and Tenured tracks. Attendees can attend either track, but the Foundational presentations are targeted to those who are new(er) to the industry while the Tenured sessions appeal more to veteran medical packaging professionals. Registration is now open, and the preliminary agenda has been released, with additional content and speakers forthcoming. Tuesday, May 9 8:45 – 9:00 a.m. Keynote Speaker: Paul Nowak, Executive Director, GreenBlue the[PACK]out 9:00 – 9:45 a.m. Sustainability Plenary Speakers: To be determined 10:00 – 11:30 a.m. “Answering the FDA Ethylene Oxide (EO) Sterilization Innovation Challenge” Approximately 50% of medical devices sold in the US every year are sterilized with ethylene oxide (EO); however, there are concerns that it is a carcinogen and harmful to sterilization workers and nearby communities. This session will introduce a packaging system that directly sterilizes medical products with a safe and effective alternative to EO while still providing the benefits of gas sterilization. Speakers: Dr. Megan Frost, Chief Technology Officer, Sterile State Kurt Yockey, Attorney, Partner at Yockey Yockey & Klarr, P.C. and President of Sterile State LLC 1:05 – 1:20 p.m. “Packaging – It’s More Than Meets the Eye: Putting the ‘Ability’ Back in Usability” Is there more to Packaging than containment and protection? We all know the answer is “Yes.” Join us to empathize and understand how there is more than meets the eye so that we can put the “Ability” back in Us-Ability! Speaker: Arti Roth, Senior Engineering Manager, Edwards Lifesciences 1:20 – 2:00 p.m. “Can your Package ‘Take a Licking’ and ‘Keep on Ticking’? How to Tackle Human Nature and Mother Nature with Robust Package Design” You’ve probably heard of Murphy’s Law: Whatever can go wrong, will go wrong. But how can you prevent Murphy from ruining your medical device packaging? The answer is robust design! Come join Brian Farison for this engaging session where he will show how robust design principles can keep Murphy away and elevate your package performance to be world class. Speaker: Brian Farison, Technical Fellow, Network Partners 3:15 – 4:30 p.m. Industry Power Hour The Industry Power Hour features representatives from various packaging and healthcare organizations. Each representative will have 10 minutes to give a brief overview of the organization, working items currently being addressed, and how to get involved. “ASTM F02 Primary Barrier Packaging Committee” Speakers: Dan Burgess, Packaging Engineering Fellow, Boston Scientific Henk Blom, VP of Research and Technology, PAXXUS “Medical Device Packaging Technical Committee (MDPTC) of the Institute of Packaging Professionals (IoPP)” Speakers: David DiVaccaro, Consultant, DiVaccaro Consulting Group Tyler Boyd, Client Solutions Manager, Network Partners “Kilmer Innovations in Packaging (KiiP)” Speaker: Hanna Harris, Packaging Engineer, Healthmark Industries “Sterilization Packaging Manufacturers Council (SPMC)” Speaker: Dhuanne Dodrill, CEO, PAXXUS “AAMI Technical Committee 198, Working Group 7 (Packaging Working Group)” Speaker: Jen Benolken, Medical Device & Regulatory Specialist, Package Engineering, DuPont Tyvek Medical Packaging “Healthcare Plastics Recycling Council (HPRC)” Speaker: Peylina Chu, PE, HPRC Executive Director, and Senior Vice President, ESG Business Strategy at Antea Group Wednesday, May 10 8:40 – 9:05 a.m. “Catalyzing Circularity: A Case Study in Adopting Certified Advanced Recycled Materials for Medical Packaging” Medical device manufacturers have an opportunity to enable circularity by driving demand for recycled plastics with certified, sustainably sourced materials that are indistinguishable from those used today. But how do we implement these materials into the packaging value chain? This case study will explore the first adoption of Eastman Eastar Renew to produce sterile barrier packaging by allocating recycled plastic waste using an ISCC ( International Sustainability & Carbon Certification ) PLUS-certified mass balance process. Speakers: Cliff Labbe, Director, Package Engineering, Johnson & Johnson MedTech Rod Patch, Senior Director, Package Engineering, Johnson & Johnson Vision the[PACK]out 9:05 – 9:30 a.m. “Unlocking the Potential of Advanced Recycling: Today’s Technology Landscape and Opportunities for Medical Packaging” Join experts from the field as they discuss today’s advanced recycling technology landscape, the role these technologies can play in bridging the circularity gap, and how they apply to commonly used medical packaging materials. Speakers: Katherine Hofmann, Sustainability Strategic Initiatives Manager, Eastman Zach Patterson 9:30 – 10:00 a.m. “Creating a Business Case for Advanced Recycled Materials: Critical Questions from the MDM Perspective – A KiiP Collaboration” As circular materials powered by advancing recycling technologies enter the market, medical device packaging engineers seeking to integrate these sustainably sourced materials face many questions from their stakeholders. This crowd-sourced, engaging session will highlight critical questions raised from the medical device manufacturer (MDM) perspective, the journey to effectively satisfy these questions, and how the industry can collaborate to accelerate the path to circularity. Speakers: Deepa Rampura, Manager, Packaging Engineering, Intuitive Surgical Anna Thomas, Associate Manager of Packaging, SeaSpine 10:30 –11:00 a.m. — Foundational Track “Using Damage Boundary Theory as a Tool for Sustainability” In this talk, we are going to expand beyond the sterile barrier system and look at larger capital medical equipment, which requires a specifically engineered cushion design. We will explore the Damage Boundary method using the guidelines of ASTM D3332, which is used to characterize product fragility. When product fragility testing has been conducted, the cushion system can then be designed to optimize packaging. Speaker: Nora Crivello, President & CEO, Westpak 10:30 – 11:00 a.m. — Tenured Track “Reducing Sealing Variability and Increasing Process Capability” Speakers: Lynne Barton Ben White 11:00 –11:30 a.m. — Foundational Track “Wicked Stability: Project Progress and Workstream Updates” As this team continues on the journey of changing how our industry thinks about material stability, we are learning new ways to reveal and test for degradation. We’ll discuss these learnings as well as the addition of several new project workstreams focused on bringing in additional information to support our hypothesis. Speakers: Nancy Battaglini, Sr. Principal Packaging Engineer, Medtronic Jen Benolken, Medical Device & Regulatory Specialist, Package Engineering, DuPont Tyvek Medical Packaging Henk Blom, VP of Research and Technology, PAXXUS Rod Patch, Senior Director, Package Engineering, Johnson & Johnson Vision the[PACK]out 11:00 –11:30 a.m. — Tenured Track To be determined 1:00 – 1:30 p.m. — Foundational Track “Building a Plane While Flying is Not Easy – Learn How ASTM is Developing a Guide to Help the Industry Meet or Exceed Requirements of ISO 11607 Section 7” This interactive and engaging presentation covers a practical approach of using the ASTM Usability Guidance to meet the mandatory minimums and enhance the quality of usability studies with suggested best practices. Speakers: Broc Couling, Principal Packaging Engineer, Smith+Nephew Arti Roth, Senior Engineering Manager, Edwards Lifesciences Matt TerBush, Senior Laboratory Packaging Engineer, Packaging Compliance Labs 1:00 – 1:30 p.m. — Tenured Track To be determined 1:35 – 2:10 p.m. — Foundational Track “End-of-Life Journey of Medical Packaging: What You Should Know as a Packaging Engineer” Do you know where medical packaging waste goes? What is truly recyclable and what is actually being recycled today? How are recycling capabilities evolving globally and how does this impact the healthcare industry? Join this panel of experts as we answer these questions and more while examining the end-of-life journey for medical packaging. Speakers: Jamie Pero Parker, Sustainability Sector Lead, RTA Innovation Advisor Samantha Smith, Director of Product Stewardship, Medtronic Keith Weitz, Director of the Sustainability and Resource Management Program, RTI International 1:35 – 2:10 p.m. — Tenured Track “Human Factors Engineering: How to Incorporate Usability Principles and Practices to Packaging Design to Create Safe and Effective Product-Packaging Systems for Your Users” Is packaging just a container? Learn how human factors engineering (HFE) and usability principles and practices can be applied to packaging design to satisfy user requirements beyond regulatory requirements. Speaker: David Grosse-Wentrup, Research Director, Design Science the[PACK]out 2:15 – 2:45 p.m. — Foundational Track “Sterile Packaging Recycling Pilots: A Journey to Circularity” The DuPont Tyvek Healthcare Packaging team leveraged learnings and relationships made through involvement in the Healthcare Plastics Recycling Council to help set up and execute healthcare plastics recycling pilot programs. We’ll take you through this journey from planning, education, implementation, and bumps along the way as we strived to collect and redirect healthcare plastics away from landfill and incineration to advanced recycling processes to help drive circularity. Speaker: Nick Packet, Healthcare Industry Vertical Manager, DuPont 2:15 – 2:45 p.m. — Tenured Track “Connected Combination Devices Elevate User Experience” As popularity of and demand for combination devices skyrocket, packaging innovations are vital to meet functional and marketing needs. In this Q&A presentation, veteran journalist Lisa Pierce elicits insights and advice from drug-delivery device expert Mathias Romacker. Speakers: Mathias Romacker, Executive Advisor, Kymanox Lisa Pierce, Executive Editor, Packaging Digest 3:15 – 3:45 p.m. — Foundational Track “Human Sustainability through Connection and Vulnerability” Step into a new mindset with the panel as they break down intimidating barriers and common misconceptions in industry. This high-energy Q&A will pull from panelists’ personal experiences and reveal the benefits of human sustainability through personal and professional development. Speakers: Hanna Harris, Packaging Engineer, Healthmark Industries Chris Kelley, R&D Packaging Engineer, Coloplast Austin Liu, Senior Package Engineer, Johnson & Johnson Surgical Vision Seema Momin, Global Account Manager, PAXXUS Moderator: Jen Benolken, Medical Device & Regulatory Specialist, Package Engineering, DuPont Tyvek Medical Packaging 3:15 – 3:45 p.m. — Tenured Track “Medical Packaging from the Patient’s Perspective” When I was 13 years old, I was diagnosed with a large cancerous brain tumor. While in the hospital, something that I did not like was how loud the packaging was, especially pouches being torn open. The goal of my presentation is to bring awareness about sound caused by medical packaging. I also wish to form a research team to find ways to make medical packaging quieter. Speaker: Michael Johnston, Packaging Engineer, MicroAire Surgical Instruments 3:50 – 3:55 p.m. “TED-Style Talks” In this session, we will hear three TED-style talks that represent various phases of package validation. We will start with defining your distribution channels to design a proper validation plan. Taking that information, we will dive into how to choose protocols that satisfy both the distribution challenges and intricacies of ISO 11607. Wrapping up, we’ll challenge the status quo and discuss the possibility of leveraging validations for like-packaging. We will wrap up the hour with a Q&A session. 3:50 – 3:55 p.m. — Foundational Track “TED-Style Talks” To be determined Session Intro Speaker: Nora Crivello 3:50 – 3:55 p.m. — Tenured Track “TED-Style Talks” To be determined Session Intro Speaker: Paul Nowak 3:55 – 4:10 p.m. — Tenured Track “Packaging Groundhog Day: How Do We Challenge the Status Quo?” As engineers in the medical industry, we face a great deal of barriers when bringing a product to market. The largest challenge we face is short timelines due to packaging being the last thought prior to launch. How can we be innovative as an industry while facing these challenges? During this presentation, we will walk through challenges the SDC has faced through implementation of new material combinations and the path to execution. Speaker: Nancy Battaglini, Sr. Principal Packaging Engineer, Medtronic 4:10 – 4:25 p.m. — Foundational Track “What is SBS Package Performance Testing 1, 2, 3 …” ISO 11607 requires performance testing for sterile barrier systems. This talk will discuss applying the intricacies of ISO 11607 performance testing in the laboratory to simulate the distribution environment and successfully validate the packaging. Speaker: Jan Gates, President/Advisor Packaging Engineer, Adept Group 4:10 – 4:25 p.m. — Tenured Track To be determined 4:25 – 4:40 p.m. — Foundational Track “Comparing Impact of Distribution Hazards on Similar Packaging Systems – Adopting Bracketing Approaches to Meet Compliance” Speaker: Seema Momin, Global Account Manager, PAXXUS t Group 4:25 – 4:40 p.m. — Tenured Track To be determined 4:40 – 4:55 p.m. — Foundational Track Q&A with Speakers Moderator: Nora Crivello 4:40 – 4:55 p.m. — Tenured Track Q&A with Speakers Moderator: Paul Nowak Thursday, May 11 8:30 – 8:45 a.m. Introduction to Day Three Workshop the[PACK]out 8:45 – 11:20 a.m. Workshop 11:20 a.m. – 12:00 p.m. Live Q&A | Closing Remarks

眼力健（上海）医疗器械贸易有限公司报告，由于涉及特定型号、特定批次产品过期，生产商强生视力康公司Johnson & Johnson Surgical Vision, Inc.对其生产的一次性LAMINAR层流超乳探针和灌注套管（国械注进20173166671，国械注进20193160370）主动召回。召回级别为二级召回。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。 附件：医疗器械召回事件报告表 2023年3月14日眼力健（上海）医疗器械贸易有限公司附件.pdf