MAUDE Adverse Event Report: TEARSCIENCE, INC. MEIBOMIAN GLAND EVALUATOR; CAMERA, OPHTHALMIC, AC-POWERED

Model Number	DMI-1000
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system was sitting idle and a puff of smoke came out and their was a burning smell and now will not power on.No additional information was provided.
Additional Manufacturer Narrative
Section a2 a3, a4 and a5: not applicable.Section d6a: if implanted, give date: not applicable, as the device is not an implantable.Section d6b: if explanted, give date: not applicable, as the device is not an implantable.Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history record and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Additional information: section h3: device evaluated by manufacturer: yes.Device evaluation: the device was repaired by repairing the defecting central processing unit (cpu) as the c22 had shorted out and burned.System performing to specification.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Correction: section h4 - device manufacture date: in initial report, the manufacturer date provided was inadvertently reported as 08/20/2018, however the correct date is 01/22/2018.Additional information: manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as it cannot be determined that the issue is traced to the design, manufacturing, or labeling, product deficiency cannot be confirmed.Based on the information obtained, product malfunction was confirmed and a non-conformance investigation was conducted.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: MEIBOMIAN GLAND EVALUATOR
• Common Device Name: CAMERA, OPHTHALMIC, AC-POWERED
• Manufacturer (Section D): TEARSCIENCE, INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 22458471
• Report Number: 3012236936-2025-000188
• Device Sequence Number: 8383695
• Product Code: HKI
• UDI-Device Identifier: 00859623006919
• UDI-Public: (01)00859623006919
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K182506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2026

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 Model Number: DMI-1000
• Device Catalogue Number: REF-400000
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/24/2025; 02/12/2026
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/19/2025; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown