MAUDE Adverse Event Report: BAUSCH + LOMB, INC. TRUCURVE LASER PROBE FOR 25GA SURGERY; OPHTHALMIC LASER SYSTEM BEAM GUIDE

Model Number	55.23.25
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Codes	Retinal Injury (2048); Visual Disturbances (2140); Eye Burn (2523)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Although requested, the lot number was not provided, therefore the udi-pi is not available.Without a lot number, no device history record review could be conducted.The most probable root cause of this event is unknown/inconclusive.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is complete.
Event or Problem Description
A user facility in the netherlands reported that the laser output was too low.Settings were adjusted to the highest and there was no stable output.As a result, the patient experienced a retinal burn.
Additional Manufacturer Narrative
Additional information: section b5.The investigation is complete.
Event or Problem Description
Additional information was received.The corneal burn caused permanent loss (a blind spot) on the place the retina was burned with the laser.There was no overall loss of vision.

• Brand Name: TRUCURVE LASER PROBE FOR 25GA SURGERY
• Common Device Name: OPHTHALMIC LASER SYSTEM BEAM GUIDE
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 4100 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre dr.; o'fallon MO 63368
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263089
• MDR Report Key: 22038478
• Report Number: 0001932402-2025-00002
• Device Sequence Number: 15530548
• Product Code: HQB
• UDI-Device Identifier: 20841305106653
• UDI-Public: (01)20841305106653
• Combination Product (Y/N): N
• PMA/510(K) Number: K954307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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 Model Number: 55.23.25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 07/07/2024
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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