MAUDE Adverse Event Report: PT. CIBA VISION BATAM LASER PROBES; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Catalog Number	8065750991
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during the vitrectomy, ophthalmic laser probe tip could not be inserted into the trocar cannula.The energy of laser probe hasn't been tested because the laser probe could not be inserted, connection to device and test were normal.After replacing with a new laser probe, the surgery was successfully completed.No patient harm.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, a laser probe was returned for testing on this investigation.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for ¿complaints reported against this serial number¿ was performed.No similar complaints were reported for this product serial number (under investigation).A laser probe was returned for testing on this investigation.A visual assessment of the returned sample revealed no obvious nonconformities.The returned sample was slowly inserted into a 23ga trocar and passed through without any resistance; consequently, there was no problem found inserting the laser probe into the trocar.The returned laser probe was found to have no problem.Therefore, the root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: LASER PROBES
• Common Device Name: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer (Section G): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23905220
• Report Number: 9681121-2025-00202
• Device Sequence Number: 13048410
• Product Code: HQE
• UDI-Device Identifier: 00380657509911
• UDI-Public: (01)00380657509911(17)270630(11)240719(10)31578299
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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 Catalogue Number: 8065750991
• Device Lot Number: 31578299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown