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

Catalog Number	8065751114
Medical Device Problem Codes	Fitting Problem (2183); Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that an ophthalmic laser probe was resistance and was difficult to insert into the console during setup.The surgery was performed and completed after replacing the product with another one.Procedure details and patient harm was not reported.Additional information has been requested and none received till date.
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).
Additional Manufacturer Narrative
Additional information provided in sections d9, h3, h6 and h11.A non-conformance based review of the lot 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 lot number was performed.No similar complaints were reported for the product lot under investigation.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.A sample was received at the manufacturing site.A visual assessment of the returned sample revealed no visual nonconformities.A fit check was performed on the returned sample with a trocar, and resistance was felt indicating foreign material.A visual assessment under a microscope was performed and found foreign material adhered to the nitinol.Refer to the attached investigation log.The customer reported that their product was difficult to insert.Sample evaluation at manufacturing site revealed the returned sample had foreign material on the nitinol.Based on the results of this investigation, the reported event was confirmed.However, it remains inconclusive about how or when the foreign material adhered to the nitinol.The root cause of the reported event is attributed to foreign material on the nitinol.Quality assurance has reviewed this complaint and 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: 23485706
• Report Number: 9681121-2025-00158
• Device Sequence Number: 13319055
• Product Code: HQE
• UDI-Device Identifier: 00380657511143
• UDI-Public: (01)00380657511143(17)280430(11)250523(10)31597874
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/23/2026

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 Catalogue Number: 8065751114
• Device Lot Number: 31597874
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown