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

Catalog Number	8065751114
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Firing Problem (4011)
Health Effect - Clinical Code	Retinal Tear (2050)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that an ophthalmic laser probe pierced the retina while the power was being reduced during a vitrectomy procedure.The surgery was completed on the same day, and the patient's current condition was unknown.
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 is provided in sections b.5 and h.6.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
Additional information received indicated that the ophthalmic laser probe had been too powerful.
Additional Manufacturer Narrative
Additional information is provided in sections h.6 and h.11.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.There was no product returned on this investigation.Based on the information obtained, the root cause of the reported event is inconclusive.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 the product serial under investigation.Based on the information obtained, 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: 22628656
• Report Number: 9681121-2025-00079
• Device Sequence Number: 12759963
• Product Code: HQE
• UDI-Device Identifier: 00380657511143
• UDI-Public: (01)00380657511143(17)270630(11)240717(10)31578197
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065751114
• Device Lot Number: 31578197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 10/22/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/28/2025; 11/14/2025
• Date Device Manufactured: 07/17/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown