MAUDE Adverse Event Report: BAUSCH + LOMB 25GA FLEXIBLE TAPERED ILLUMINATED LASER PROBE; OPHTHALMIC LASER SYSTEM BEAM GUIDE

Model Number	55.70.25P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that during procedure the surgeon experienced a variable uptake on the laser on the retina.Settings were power 300, duration 100, interval 100.The duration was raised to 200, however the uptake was still variable.As a result the doctor experienced a hot burn that caused a break on the retina.A laser retinopexy was performed to treat the break.The case was completed without further complication.
Additional Manufacturer Narrative
The device was discarded and cannot be returned for evaluation.Review of device history record, trend analysis, risk assessment, and directions for use is underway.The investigation is ongoing.
Additional Manufacturer Narrative
The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, no causal factors can be determined and no conclusion can be drawn.The investigation is complete.

• Brand Name: 25GA FLEXIBLE TAPERED ILLUMINATED LASER PROBE
• Common Device Name: OPHTHALMIC LASER SYSTEM BEAM GUIDE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3845 corporate centre dr.; o''fallon, MO 63368 ; 6362263220
• MDR Report Key: 18425924
• Report Number: 0001932402-2024-70001
• Device Sequence Number: 8089193
• Product Code: HQB
• UDI-Device Identifier: 20841305107094
• UDI-Public: (01)20841305107094(17)260718(11)230810(10)M0049597
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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 Expiration Date: 07/18/2026
• Device Model Number: 55.70.25P
• Device Lot Number: M0049597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown