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July 15, 2026
Instrument Issue Escalation Process

Document Approval Record — Version 11

Reviewer Status Date
Gene Borbone - Service Director ✓ Approved Jul 24, 2026
Darin Dixon - VP Pending —
Alicia Anselmo - Service Coordination Manager Pending —
Carlos Rangel - Service Manager Pending —
David Vincent III - Service Manager Pending —
Jean Aragundi - Service Manager Pending —
Mikulich Ryan - VP Sales Pending —
In Review Awaiting approval — 1 of 7 reviewers have signed off. Version 11

📋 Department Approvals

Gene Borbone - Service Director
Approved by Gene Borbone on Jul 24, 2026 2:43pm
Approved
Darin Dixon - VP
Pending
Alicia Anselmo - Service Coordination Manager
Pending
Carlos Rangel - Service Manager
Pending
David Vincent III - Service Manager
Pending
Jean Aragundi - Service Manager
Pending
Mikulich Ryan - VP Sales
Pending

👥 Manage Reviewers

Gene Borbone - Service Director (ID: 93) Darin Dixon - VP (ID: 68) Alicia Anselmo - Service Coordination Manager (ID: 54) Carlos Rangel - Service Manager (ID: 25) David Vincent III - Service Manager (ID: 231) Jean Aragundi - Service Manager (ID: 1) Mikulich Ryan - VP Sales (ID: 1029)
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🕘 Version History — currently editing Version 11

Version 10 — Instrument Issue Escalation Process
Jul 24, 2026 2:43pm by Gene Borbone
Version 9 — Instrument Installation Issue Escalation Process
Jul 24, 2026 10:57am by Jean
Version 8 — Instrument Installation Issue Escalation Process
Jul 23, 2026 2:47pm by Jean
Version 7 — APH550
Jul 23, 2026 2:47pm by Jean — Restored from version 6
Version 6 — Instrument Installation Issue Escalation Process
Jul 23, 2026 2:47pm by Jean
Version 5 — Instrument Installation Issue Escalation Process
Jul 23, 2026 2:13pm by Jean
Version 4 — Instrument Installation Issue Escalation Process
Jul 22, 2026 5:18pm by Jean
Version 3 — Instrument Installation Issue Escalation Process
Jul 22, 2026 5:18pm by Jean
Version 2 — Instrument Installation Issue Escalation Process
Jul 22, 2026 5:16pm by Jean
Version 1 — Instrument Installation Issue Escalation Process
Jul 22, 2026 1:45pm by Jean — Creation

1.0 PURPOSE

  1. To identify and document issues found during installation or support of Essilor Instruments ophthalmic products.
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Procedure Owner -- Manager of Service Coordination. To require sign-off from a department, use the Manage Reviewers panel above instead of typing it here.
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2.0 SCOPE

  1. When performing the task of installation or supporting Essilor Products and an issue is found, the installer must document the state of the equipment. Capture any software error codes, physical defects, or calibration failures. Take clear photographs of physical damage, incorrect wiring, or faulty optics alignment. Note the equipment model number, software version, and serial number.
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3.0 RESPONSIBILITY

  1. It is the responsibility of the Manager of Technical Services to ensure that this procedure is continuously managed and sustainable.
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4.1 REFERENCES

  1. Product Issue Intake Form
  2. CAPA Form
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4.2 ATTACHMENTS

No structural criteria logged.
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5.1 PROCEDURE

  1. Installer or Servicing Technician – Any certified technician or salesperson completing the installation or support of Essilor Instruments.
  2. Aprimo - Essilor Instruments Controlled Database for filling claims of product defects, packaging issues, missing accessory or software failures.
  3. Stakeholders – Quality Assurance, technical, and management teams dedicated to resolving product issues in a timely manner.
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5.2 PROCESS

  1. Log the product issue in the EI Portal/Service Hub – Product Issue Intake Form.
  2. Include the installation checklist or work order status, the exact point of failure, and the documented pictures if available.
  3. Categorize the issue severity: Critical: System inoperable, safety hazard, or dead on arrival (DOA). Major: System functional but fails specific diagnostic, calibration, or software validation tests. Minor: Cosmetic defects or missing non-critical accessories that don't halt core functionality.
  4. ESCALATION TO ESSILOR QUALITY When an Essilor Instrument is found to have any product issues, a product claim must be entered in Aprimo. Included in the details would be the device name, model, serial number and a description of the issue.
  5. ESCALATION TO MANUFACTURER Contact the ophthalmic product manufacturer's technical support or your designated account representative. Provide them with your internal ticket details and hardware serial numbers. Request an official case/RMA (Return Merchandise Authorization) number and an estimated timeline for a replacement dispatch or replacement parts.
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5.3 FINALIZATION

  1. POST RESOLUTION Once the manufacturer resolves the issue (via repair, patch, or replacement), perform a full re-verification of the installation checklist. Log the resolution details in the Service Management Database. If the issue stems from a systemic vendor defect, trigger an internal Corrective and Preventive Action (CAPA) review.
  2. MONTHLY REVIEW A monthly review meeting will be held between the stakeholders of US and France Quality Assurance. During the meeting, product issues will be reviewed to validate the escalation of open issues or closeout of product issues.
  3. Regulatory Reminder: If the installation issue involves a malfunction that could cause or contribute to a death or serious injury, it must be evaluated under FDA Medical Device Reporting (MDR) regulations (or equivalent international vigilance frameworks) for potential adverse event reporting.
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